This document outlines regulations for controlling human pharmaceutical products in a national system. It establishes the Ministry of Health and the Institute of Public Health as the competent authorities responsible for regulating pharmaceutical activities including registration, manufacturing, distribution, and advertising. It also assigns responsibilities to Regional Health Departments for authorizing product admission and enforcing compliance. Finally, it provides definitions for 29 key terms related to pharmaceutical quality, safety, and regulation.
This document provides an overview of the electronic Common Technical Document (eCTD) format used for regulatory drug submissions. It discusses the history and goals of the ICH and eCTD, the components and structure of an eCTD, best practices for preparing documents, and software options. Key points covered include the folder structure, use of XML and metadata, concept of reuse and granularity, and comparing the benefits of eCTD to traditional paper submissions. The conclusion emphasizes that adopting eCTD is essential to joining the electronic bandwagon, while also needing intermediate steps to fully transition from paper CTD formats.
Investigational new drug ,orange book,understanding on 505(b) (2) applicationsswrk
This document discusses investigational new drug applications, the Orange Book, and 505(b)(2) applications. It provides an overview of the IND process including when an IND is needed, the content of an IND application, annual reporting requirements, and classifications of INDs. It also describes the Orange Book's listing of approved drugs and their therapeutic equivalence ratings. Finally, it gives a brief explanation of 505(b)(2) applications, including what products are allowed and examples of 505(b)(2) NDAs.
The document discusses pharmaceutical regulations in Japan. It notes that Japan has the second largest pharmaceutical market behind the US. It also discusses regulations for clinical trials, marketing approval, and post-marketing safety measures. The key regulatory bodies are the Ministry of Health, Labor and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA). Pharmaceutical companies must follow good manufacturing practice (GMP) standards and obtain various approvals to market and sell drugs in Japan.
The document provides an overview of medical device registration in China. It discusses the Chinese regulatory environment and key organizations like the China Food and Drug Administration (CFDA). The CFDA classifies medical devices and oversees the registration process, which involves choosing an agent, submitting documentation, conducting tests, making two submissions for review, and final administrative approval. Attention to small details and unpredictability are characteristics of the Chinese process.
Disclaimer:
I have created this document with inputs from various sources. Some are taken right from slideshare. I just try to make this topic little compact and lucid, so that everybody can understand it easily
I am very much thankful to the original authors also, don't think I am just doing plagarism.
This document discusses dossier preparation and submission for regulatory approval of pharmaceutical products. It defines a dossier as a collection of documents on a subject used to propose approval of a new drug. Dossiers contain administrative, quality, nonclinical, and clinical data. Common dossier formats include CTD, ACTD, and eCTD, which are used globally and in various regions. Careful compilation, review, and planning is required to ensure dossiers meet all regulatory requirements for submission.
Medical Devices Rules 2017 Implementationshashi sinha
Medical Devices Rules are now enforced for all medical devices. It is important to know about the MDR 2017 and how it affects the Manufacturers, Importers and Distributors of Medical Devices and status of implementation.
The document discusses the role of Chemistry, Manufacturing, and Controls (CMC) regulatory affairs in managing post-approval changes to drugs. It explains that CMC regulatory affairs professionals work to assure drug quality from clinical trials through marketing by determining the appropriate regulatory submissions for manufacturing changes. They assess proposed changes and provide initial and final responses on whether a prior approval supplement, changes-being-effected supplement, annual report, or no submission is required. This change control process involves interactions with manufacturing and consideration of regulations, guidance, and potential effects on drug quality and equivalence.
This document provides an overview of the electronic Common Technical Document (eCTD) format used for regulatory drug submissions. It discusses the history and goals of the ICH and eCTD, the components and structure of an eCTD, best practices for preparing documents, and software options. Key points covered include the folder structure, use of XML and metadata, concept of reuse and granularity, and comparing the benefits of eCTD to traditional paper submissions. The conclusion emphasizes that adopting eCTD is essential to joining the electronic bandwagon, while also needing intermediate steps to fully transition from paper CTD formats.
Investigational new drug ,orange book,understanding on 505(b) (2) applicationsswrk
This document discusses investigational new drug applications, the Orange Book, and 505(b)(2) applications. It provides an overview of the IND process including when an IND is needed, the content of an IND application, annual reporting requirements, and classifications of INDs. It also describes the Orange Book's listing of approved drugs and their therapeutic equivalence ratings. Finally, it gives a brief explanation of 505(b)(2) applications, including what products are allowed and examples of 505(b)(2) NDAs.
The document discusses pharmaceutical regulations in Japan. It notes that Japan has the second largest pharmaceutical market behind the US. It also discusses regulations for clinical trials, marketing approval, and post-marketing safety measures. The key regulatory bodies are the Ministry of Health, Labor and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA). Pharmaceutical companies must follow good manufacturing practice (GMP) standards and obtain various approvals to market and sell drugs in Japan.
The document provides an overview of medical device registration in China. It discusses the Chinese regulatory environment and key organizations like the China Food and Drug Administration (CFDA). The CFDA classifies medical devices and oversees the registration process, which involves choosing an agent, submitting documentation, conducting tests, making two submissions for review, and final administrative approval. Attention to small details and unpredictability are characteristics of the Chinese process.
Disclaimer:
I have created this document with inputs from various sources. Some are taken right from slideshare. I just try to make this topic little compact and lucid, so that everybody can understand it easily
I am very much thankful to the original authors also, don't think I am just doing plagarism.
This document discusses dossier preparation and submission for regulatory approval of pharmaceutical products. It defines a dossier as a collection of documents on a subject used to propose approval of a new drug. Dossiers contain administrative, quality, nonclinical, and clinical data. Common dossier formats include CTD, ACTD, and eCTD, which are used globally and in various regions. Careful compilation, review, and planning is required to ensure dossiers meet all regulatory requirements for submission.
Medical Devices Rules 2017 Implementationshashi sinha
Medical Devices Rules are now enforced for all medical devices. It is important to know about the MDR 2017 and how it affects the Manufacturers, Importers and Distributors of Medical Devices and status of implementation.
The document discusses the role of Chemistry, Manufacturing, and Controls (CMC) regulatory affairs in managing post-approval changes to drugs. It explains that CMC regulatory affairs professionals work to assure drug quality from clinical trials through marketing by determining the appropriate regulatory submissions for manufacturing changes. They assess proposed changes and provide initial and final responses on whether a prior approval supplement, changes-being-effected supplement, annual report, or no submission is required. This change control process involves interactions with manufacturing and consideration of regulations, guidance, and potential effects on drug quality and equivalence.
This presentation covered the defination of dmf , importance of dmf filing , procedure of it , time period , requirement of dmf , letter of authorization meaning ,content of dmf , types of dmf
The document provides an overview of the requirements and guidelines for generic drug dossiers using the ASEAN Common Technical Document (ACTD) format. It describes the organization of the ACTD, which contains four parts covering administrative data, quality documents, nonclinical documents, and clinical documents. Part I includes the table of contents, administrative information, and product information. Part II focuses on quality documents for the drug substance and product. Parts III and IV are generally not applicable for generic drugs. The document also lists the types of documents required to complete each part of the ACTD for a generic drug application.
The document discusses regulations for drug submissions and applications in the US and other countries. It covers the major regulatory bodies like the FDA and EMA. It then focuses on the different types of applications filed with the FDA - Drug Master Files (DMF), Investigational New Drug Application (IND), New Drug Application (NDA), and Abbreviated New Drug Application (ANDA). The ANDA process for generic drugs is summarized, including requirements for bioequivalence testing and patent certification in the Orange Book.
cmc [ chemistry manufacturing control ]Akshay Patil
This document provides information about Chemistry, Manufacturing and Controls (CMC) regulatory affairs. It discusses the responsibilities of CMC regulatory affairs in providing leadership, strategy and regulatory knowledge to achieve approval of pharmaceutical products. It also summarizes key elements included in CMC regulatory submissions like manufacturing sites, analytical methods and quality testing data. The document further discusses post-approval regulatory requirements including post-approval studies and safety surveillance. It provides examples of combination products and medical device regulations. It introduces the Common Technical Document (CTD) format for registration applications and its electronic version (eCTD). Finally, it summarizes some key ICH guidelines.
Regulatory approval process for invitro diagnostics in usVinod Raj
This document summarizes the regulatory approval process for in vitro diagnostics (IVDs) in the United States. IVDs are classified into Class I, II, or III based on risk, with Class III devices requiring premarket approval. The main regulatory pathways for approval are 510(k) premarket notification for demonstrating substantial equivalence to a predicate device or the premarket approval (PMA) process for novel high-risk devices. Clinical Laboratory Improvement Amendments also provide quality standards for lab testing. The document reviews the classification system and options for 510(k), PMA, de novo, and lab developed tests.
regulatory requirnment and approval procedure for drugs and cosmetics, medica...sandeep bansal
This document outlines the regulatory requirements and approval procedures for drugs, cosmetics, medical devices, biological products, herbal medicines, and foods/nutraceuticals in India. It discusses the key regulatory bodies like the Central Drugs Standard Control Organization (CDSCO) and the application processes. For drugs, the new drug approval procedure is described involving applying to the DCGI and undergoing clinical trials and reviews. For other products, the document explains the application forms and documents required for approval from bodies like FSSAI.
Code of federal regulations {cfr} in pharmaceuticalArabinda Changmai
The Code of Federal Regulations (CFR) contains the general and permanent rules published by the executive departments and agencies of the federal government of the United States. Title 21 of the CFR governs food and drugs and is divided into three chapters addressing the Food and Drug Administration, Drug Enforcement Administration, and Office of National Drug Control Policy. Chapter I includes regulations for clinical trials, Good Laboratory Practices, food labeling, and current good manufacturing practices for pharmaceuticals. Title 21 provides the framework for approval of new drugs and biologics in the United States.
This ppt provides a brief overview of the regulatory evaluationprocess for New Applications under various types - Mutual recognition process, Decentralized procedure along with an overview of Grouping variations & Worksharing procedures.
Regulatory requirements for API and BiologicsSimranDhiman12
The document discusses regulatory requirements for active pharmaceutical ingredients (APIs) and biologics. It provides an overview of regulatory guidelines for APIs, including requirements for registration of APIs with agencies like the FDA. It also describes regulatory filings like Drug Master Files (DMFs) that are submitted to provide confidential manufacturing information to support applications. Requirements for biologics are also briefly covered, noting they are complex molecules produced through biotechnology.
New Drug Application(Nda) Vs Abbreviated New Drug Application (Anda)Vamsikrishna Reddy
The document summarizes the key differences between a New Drug Application (NDA) and an Abbreviated New Drug Application (ANDA). An NDA is required for approval of new pharmaceuticals and contains extensive nonclinical and clinical data to establish safety and effectiveness. An ANDA is for generic drugs and contains bioequivalence data comparing it to an existing approved drug, but does not require new clinical trials. The review process is shorter for ANDAs compared to NDAs. The document also discusses patent certification requirements for ANDAs and exclusivity periods for orphan drugs.
Combinational products & medical devicesSHUBHAMGWAGH
This document provides an overview of regulations for combination products and medical devices in India. It defines combination products as those composed of two or more medical products like drugs, devices, and/or biologics. The regulatory authorities in India that oversee drugs and medical devices are described, including the Drugs Controller General of India and Central Drugs Standard Control Organization. The document outlines some key proposed regulations like the Indian Medical Device Regulatory Act, which would classify medical devices into four risk-based categories and establish design, manufacturing, and post-market surveillance requirements. It also discusses the role of pharmacists in understanding medical device safety and being involved in their regulation.
The document discusses Chemistry, Manufacturing and Controls (CMC) and its role in pharmaceutical product development and regulatory approval. It provides details on:
- The key functions of CMC including process development, facility inspections, and ensuring compliance.
- CMC content requirements for different application types like NDAs, ANDAs, and INDs.
- How the CMC section evolves over clinical trial phases from laboratory to commercial scale.
- Procedures for developing and submitting post-approval study protocols to regulatory agencies.
Medical & Healthcare Products Regulatory Agency (MHRA)PriyalBagwe
The MHRA is a UK government agency responsible for regulating medicines and medical devices. It was formed in 2003 by merging the Medical Control Agency and Medical Devices Agency. The MHRA aims to protect public health by regulating products to ensure acceptable safety and efficacy profiles. It also aims to educate the public about risks and benefits of products. The MHRA board is composed of a non-executive chairman, six non-executive members, and the agency's chief executive officer. Key functions of the MHRA include regulating clinical trials, assessing safety and efficacy of products for marketing authorization, inspecting manufacturers, and enforcing statutory guidelines.
The document discusses different procedures for obtaining marketing authorization for medicinal products in the European Union. It describes the national authorization procedure which allows approval in a single member state, as well as the centralized procedure which provides an authorization that applies across all EU states. It also outlines the mutual recognition and decentralized procedures, which allow authorization in multiple states via coordination between countries. Key steps, timelines and responsibilities of each process are defined in detail.
The Hatch-Waxman Act established regulations for generic drugs in the US to facilitate generic competition. It created an Abbreviated New Drug Application process for generics to gain approval more quickly by showing bioequivalence to branded drugs. The first generic to challenge a patent via Paragraph IV certification gains 180 days of marketing exclusivity. The Act also allows patent term extensions for branded drugs to compensate for regulatory approval times. While increasing generic competition, it provides benefits to branded manufacturers such as data and market exclusivities as well as patent dispute resolutions.
This document outlines the requirements and contents of an Investigator's Brochure (IB), which provides investigators involved in clinical trials with information on the investigational product. The IB includes a summary of relevant nonclinical and clinical data, including pharmacology, toxicology from animal studies, pharmacokinetics in humans, safety and efficacy results from previous clinical trials, and marketing experience with the product. It also provides guidance to investigators on conducting the clinical trial safely and effectively. The goal of the IB is to inform investigators about the rationale for the clinical trial and enable them to independently assess the risk-benefit of the investigational product.
The document discusses the ASEAN Common Technical Dossier (ACTD) format for pharmaceutical product registration applications submitted to ASEAN regulatory authorities. The ACTD format aims to standardize applications to reduce submission time and resources while facilitating regulatory review. It includes four parts covering administrative data, quality, nonclinical, and clinical information. The ACTD guideline describes the sections within each part, including overviews, summaries, study reports, and references. The standard format seeks to provide a consistent and transparent presentation of technical information to support evaluation and understanding of registration applications.
This executive decree modifies regulations regarding the health registration of biological and biotech products in Panama. It establishes new requirements for registering biotech products, including presenting clinical trial data, quality and manufacturing information, risk management programs, and certificates of analysis for each imported batch. Biotech products already registered must now present clinical trials within 60 days to maintain their registration. The decree aims to ensure the efficacy, safety and quality of biopharmaceuticals marketed in Panama.
El documento presenta las instrucciones para un juego de mesa sobre el Camino de Santiago. Los jugadores deben avanzar por un tablero contestando preguntas sobre la ruta y la ciudad de Santiago. El juego se puede jugar de forma individual o por equipos. El objetivo es ser el primero en llegar a la Catedral de Santiago respondiendo correctamente a las preguntas.
This presentation covered the defination of dmf , importance of dmf filing , procedure of it , time period , requirement of dmf , letter of authorization meaning ,content of dmf , types of dmf
The document provides an overview of the requirements and guidelines for generic drug dossiers using the ASEAN Common Technical Document (ACTD) format. It describes the organization of the ACTD, which contains four parts covering administrative data, quality documents, nonclinical documents, and clinical documents. Part I includes the table of contents, administrative information, and product information. Part II focuses on quality documents for the drug substance and product. Parts III and IV are generally not applicable for generic drugs. The document also lists the types of documents required to complete each part of the ACTD for a generic drug application.
The document discusses regulations for drug submissions and applications in the US and other countries. It covers the major regulatory bodies like the FDA and EMA. It then focuses on the different types of applications filed with the FDA - Drug Master Files (DMF), Investigational New Drug Application (IND), New Drug Application (NDA), and Abbreviated New Drug Application (ANDA). The ANDA process for generic drugs is summarized, including requirements for bioequivalence testing and patent certification in the Orange Book.
cmc [ chemistry manufacturing control ]Akshay Patil
This document provides information about Chemistry, Manufacturing and Controls (CMC) regulatory affairs. It discusses the responsibilities of CMC regulatory affairs in providing leadership, strategy and regulatory knowledge to achieve approval of pharmaceutical products. It also summarizes key elements included in CMC regulatory submissions like manufacturing sites, analytical methods and quality testing data. The document further discusses post-approval regulatory requirements including post-approval studies and safety surveillance. It provides examples of combination products and medical device regulations. It introduces the Common Technical Document (CTD) format for registration applications and its electronic version (eCTD). Finally, it summarizes some key ICH guidelines.
Regulatory approval process for invitro diagnostics in usVinod Raj
This document summarizes the regulatory approval process for in vitro diagnostics (IVDs) in the United States. IVDs are classified into Class I, II, or III based on risk, with Class III devices requiring premarket approval. The main regulatory pathways for approval are 510(k) premarket notification for demonstrating substantial equivalence to a predicate device or the premarket approval (PMA) process for novel high-risk devices. Clinical Laboratory Improvement Amendments also provide quality standards for lab testing. The document reviews the classification system and options for 510(k), PMA, de novo, and lab developed tests.
regulatory requirnment and approval procedure for drugs and cosmetics, medica...sandeep bansal
This document outlines the regulatory requirements and approval procedures for drugs, cosmetics, medical devices, biological products, herbal medicines, and foods/nutraceuticals in India. It discusses the key regulatory bodies like the Central Drugs Standard Control Organization (CDSCO) and the application processes. For drugs, the new drug approval procedure is described involving applying to the DCGI and undergoing clinical trials and reviews. For other products, the document explains the application forms and documents required for approval from bodies like FSSAI.
Code of federal regulations {cfr} in pharmaceuticalArabinda Changmai
The Code of Federal Regulations (CFR) contains the general and permanent rules published by the executive departments and agencies of the federal government of the United States. Title 21 of the CFR governs food and drugs and is divided into three chapters addressing the Food and Drug Administration, Drug Enforcement Administration, and Office of National Drug Control Policy. Chapter I includes regulations for clinical trials, Good Laboratory Practices, food labeling, and current good manufacturing practices for pharmaceuticals. Title 21 provides the framework for approval of new drugs and biologics in the United States.
This ppt provides a brief overview of the regulatory evaluationprocess for New Applications under various types - Mutual recognition process, Decentralized procedure along with an overview of Grouping variations & Worksharing procedures.
Regulatory requirements for API and BiologicsSimranDhiman12
The document discusses regulatory requirements for active pharmaceutical ingredients (APIs) and biologics. It provides an overview of regulatory guidelines for APIs, including requirements for registration of APIs with agencies like the FDA. It also describes regulatory filings like Drug Master Files (DMFs) that are submitted to provide confidential manufacturing information to support applications. Requirements for biologics are also briefly covered, noting they are complex molecules produced through biotechnology.
New Drug Application(Nda) Vs Abbreviated New Drug Application (Anda)Vamsikrishna Reddy
The document summarizes the key differences between a New Drug Application (NDA) and an Abbreviated New Drug Application (ANDA). An NDA is required for approval of new pharmaceuticals and contains extensive nonclinical and clinical data to establish safety and effectiveness. An ANDA is for generic drugs and contains bioequivalence data comparing it to an existing approved drug, but does not require new clinical trials. The review process is shorter for ANDAs compared to NDAs. The document also discusses patent certification requirements for ANDAs and exclusivity periods for orphan drugs.
Combinational products & medical devicesSHUBHAMGWAGH
This document provides an overview of regulations for combination products and medical devices in India. It defines combination products as those composed of two or more medical products like drugs, devices, and/or biologics. The regulatory authorities in India that oversee drugs and medical devices are described, including the Drugs Controller General of India and Central Drugs Standard Control Organization. The document outlines some key proposed regulations like the Indian Medical Device Regulatory Act, which would classify medical devices into four risk-based categories and establish design, manufacturing, and post-market surveillance requirements. It also discusses the role of pharmacists in understanding medical device safety and being involved in their regulation.
The document discusses Chemistry, Manufacturing and Controls (CMC) and its role in pharmaceutical product development and regulatory approval. It provides details on:
- The key functions of CMC including process development, facility inspections, and ensuring compliance.
- CMC content requirements for different application types like NDAs, ANDAs, and INDs.
- How the CMC section evolves over clinical trial phases from laboratory to commercial scale.
- Procedures for developing and submitting post-approval study protocols to regulatory agencies.
Medical & Healthcare Products Regulatory Agency (MHRA)PriyalBagwe
The MHRA is a UK government agency responsible for regulating medicines and medical devices. It was formed in 2003 by merging the Medical Control Agency and Medical Devices Agency. The MHRA aims to protect public health by regulating products to ensure acceptable safety and efficacy profiles. It also aims to educate the public about risks and benefits of products. The MHRA board is composed of a non-executive chairman, six non-executive members, and the agency's chief executive officer. Key functions of the MHRA include regulating clinical trials, assessing safety and efficacy of products for marketing authorization, inspecting manufacturers, and enforcing statutory guidelines.
The document discusses different procedures for obtaining marketing authorization for medicinal products in the European Union. It describes the national authorization procedure which allows approval in a single member state, as well as the centralized procedure which provides an authorization that applies across all EU states. It also outlines the mutual recognition and decentralized procedures, which allow authorization in multiple states via coordination between countries. Key steps, timelines and responsibilities of each process are defined in detail.
The Hatch-Waxman Act established regulations for generic drugs in the US to facilitate generic competition. It created an Abbreviated New Drug Application process for generics to gain approval more quickly by showing bioequivalence to branded drugs. The first generic to challenge a patent via Paragraph IV certification gains 180 days of marketing exclusivity. The Act also allows patent term extensions for branded drugs to compensate for regulatory approval times. While increasing generic competition, it provides benefits to branded manufacturers such as data and market exclusivities as well as patent dispute resolutions.
This document outlines the requirements and contents of an Investigator's Brochure (IB), which provides investigators involved in clinical trials with information on the investigational product. The IB includes a summary of relevant nonclinical and clinical data, including pharmacology, toxicology from animal studies, pharmacokinetics in humans, safety and efficacy results from previous clinical trials, and marketing experience with the product. It also provides guidance to investigators on conducting the clinical trial safely and effectively. The goal of the IB is to inform investigators about the rationale for the clinical trial and enable them to independently assess the risk-benefit of the investigational product.
The document discusses the ASEAN Common Technical Dossier (ACTD) format for pharmaceutical product registration applications submitted to ASEAN regulatory authorities. The ACTD format aims to standardize applications to reduce submission time and resources while facilitating regulatory review. It includes four parts covering administrative data, quality, nonclinical, and clinical information. The ACTD guideline describes the sections within each part, including overviews, summaries, study reports, and references. The standard format seeks to provide a consistent and transparent presentation of technical information to support evaluation and understanding of registration applications.
This executive decree modifies regulations regarding the health registration of biological and biotech products in Panama. It establishes new requirements for registering biotech products, including presenting clinical trial data, quality and manufacturing information, risk management programs, and certificates of analysis for each imported batch. Biotech products already registered must now present clinical trials within 60 days to maintain their registration. The decree aims to ensure the efficacy, safety and quality of biopharmaceuticals marketed in Panama.
El documento presenta las instrucciones para un juego de mesa sobre el Camino de Santiago. Los jugadores deben avanzar por un tablero contestando preguntas sobre la ruta y la ciudad de Santiago. El juego se puede jugar de forma individual o por equipos. El objetivo es ser el primero en llegar a la Catedral de Santiago respondiendo correctamente a las preguntas.
Guide for conducting comparability exercise for biological product registrationClapbio
This document provides guidance for conducting a comparability exercise between a proposed biological product (BP) and an authorized comparator biological product (CBP) for the purpose of biological product registration. It outlines the quality, stability, manufacturing process, and data requirements that must be evaluated and presented in a comparability study to demonstrate that the BP is similar to the CBP, upon which reduced nonclinical and clinical data can be relied. Key aspects that must be compared include quality attributes, samples from manufacturing process stages, stability under stress conditions, and data from multiple batches. Significant unjustified differences found would indicate the products are not similar.
Zipcar is a global car sharing service that provides vehicles by the hour or day to both personal and business members. It has over 650,000 members and 9,000 vehicles worldwide. Zipcar allows businesses to save time, money, and hassle compared to owning vehicles or using taxis/rental cars. Employees can reserve vehicles online or via app for meetings, errands, client meetings, and other occasions. Zipcar is also environmentally friendly by taking personally owned vehicles off the road. Business memberships provide discounted hourly rates and other benefits.
Este documento contiene las respuestas de un estudiante a varias preguntas sobre una lectura. En resumen, el estudiante opina que la actitud de dependencia de los pájaros no es buena, ya que no tienen un rumbo definido. También dice que es importante definir metas y no depender de los demás. Finalmente, el estudiante explica que su rumbo es terminar sus estudios y cumplir sus sueños a través del trabajo duro.
Este documento presenta las normas y las instrucciones de un juego de mesa sobre la ciudad de Santiago. Los jugadores avanzan por casillas tirando un dado y respondiendo preguntas sobre lugares y hechos de la ciudad. El juego contiene 23 casillas con sitios emblemáticos de Santiago y 20 preguntas sobre su historia, cultura y símbolos.
This document lists the names of several architectural projects including PREPKITCHEN Little Italy, DIGITARIA, Solace & the Mooonlight Lounge, GoPro, Davanti, UCSD International Center, and Indian Wells Tennis Garden—Shade Structure.
The document outlines the history and current state of childcare in Japan. It traces the origins of kindergartens back to 1871 and daycare centers to 1890. Today, the formal childcare system includes kindergartens overseen by the Ministry of Education for children ages 3-5, and daycare centers overseen by the Ministry of Health and Welfare for children ages 0-5. Attendance in preschool education has increased over time and there is a trend toward more free public options. The underlying philosophy focuses on teaching children etiquette, independence, and confidence. Childcare workers require specific training and certificates.
Este documento resume los conceptos básicos de la cría de Pokémon, incluyendo la selección de padres, el uso de ítems de cría para heredar ciertos IVs, y la importancia de la naturaleza para maximizar los stats de un Pokémon. Explica que la cría comienza con la elección del Pokémon y sus movimientos Egg, además de los IVs y padres importantes, y que los ítems como Everstone ayudan a heredar ciertos stats de los padres a los huevos.
La Fundación Junior Achievement Colombia, mejor conocida como Colombia Emprendedora se complace en
presentar a ustedes el programa Mujeres Emprendedoras, que se ejecutará gracias al patrocinio de Accenture
Ltda. y con la colaboración de la Fundación Ana Restrepo del Corral.
Guide for elaboration of clinical study reports for biological product regist...Clapbio
This document provides guidance on the minimum content and format required for clinical study reports submitted for biological product registration or post-registration changes. It outlines 20 sections that should be included, such as background on the study design, objectives, treatments, endpoints, results analyses, and conclusions. Adherence to this standard format will help ensure clinical reports contain all necessary information to support regulatory reviews.
The document provides guidelines for the evaluation of similar biotherapeutic products (SBPs). It outlines key principles for licensing SBPs, which include:
1) Development of a SBP involves stepwise comparability exercises starting with quality comparisons to a reference biotherapeutic product (RBP), with demonstration of similarity a prerequisite for reduced non-clinical and clinical data requirements.
2) Licensing of a SBP is based on its demonstrated similarity to a suitable RBP in quality, non-clinical, and clinical parameters.
3) Comparability exercises include integrated quality, non-clinical and clinical studies to provide comparative data between the SBP and RBP. Differences require investigation and may necessitate additional data.
The document summarizes the history and development of kindergarten and daycare centers in Japan. It notes that the first kindergarten was established in 1876, and kindergarten became part of the basic school education system in 1947 under the Ministry of Education. The first daycare center opened in 1890, and they were set up in factories starting in 1894, receiving subsidies beginning in 1908 and becoming classified as child welfare facilities in 1947 under the Ministry of Health and Welfare. Attendance rates for preschool education increased over time, reaching 100% for 4-5 year olds by 1981. Public and private kindergartens and daycares receive different levels of financial support. A basic plan from 2008 aimed to increase
La lista presenta los estudiantes con excelencia académica en el primer trimestre. Algunos de los estudiantes destacados son María Gómez, quien obtuvo las mejores calificaciones en matemáticas, y Juan Pérez, que se destacó en ciencias.
16 12 11_-_sdm_project[1] [modo de compatibilidade]Clapbio
This document outlines a research project on using shared decision making (SDM) to guide discussions about biosimilars and biological agents in Latin America. The project will involve two stages: 1) an international survey to understand stakeholders' perspectives on SDM and its applicability to biosimilars, and 2) development and testing of a decision aid tool to facilitate SDM discussions on biosimilars while accounting for cultural factors. The goal is to explore barriers to SDM implementation and develop a validated decision aid to guide discussions and priority setting around biosimilar treatment options in Latin America.
Este documento resume los conceptos básicos de la cría de Pokémon, incluyendo la selección de padres, el uso de ítems de cría para heredar ciertos IVs, y la importancia de la naturaleza para maximizar los stats de un Pokémon. Explica que la cría comienza con la elección del Pokémon y sus movimientos Egg, además de los IVs y padres importantes, y que los ítems como Everstone ayudan a heredar ciertos stats de los padres a los huevos.
This document outlines the development of an experimental enterprise called FoodLoop that tackles the urban food waste problem. The enterprise aims to get every housing estate in Britain composting food waste on site and using the compost to grow fruits and vegetables. It discusses the food waste problem, stakeholders involved, the service and system designed including food waste collection, composting, and growing food. It provides examples of other social enterprises and encourages participants to create their own enterprise idea that connects issues and fits their skills. The document promotes an approach of zooming in and out between specific problems and the bigger picture to develop solutions.
The document discusses a presentation about tourism in Guam. It outlines Guam's mission to build trust between the military and local residents through mutual respect and quality of life concerns. It provides background on Guam's history of developing tourism since 1952. Key facts are presented on Guam's hotel inventory, visitor demographics, and interest groups. A SWOT analysis identifies strengths like beaches and diving, but also weaknesses like infrastructure and attitudes. Opportunities include new Asian markets, but threats include rising costs and local activism. Main issues discussed are over-reliance on Japan, lack of identity, and low visitor retention.
A combination product is defined as a product composed of two or more regulated components (drug, device, biologic) that are combined and produced as a single entity. Combination products may be classified as drugs or devices depending on their principal mechanism of action. Health Canada and the US FDA have policies for classifying combination products and determining which agency regulations apply. The sponsor can request a classification from the agencies, which will consider the product's components and principal mechanism of action.
REGULATIONS FOR COMBINATION PRODUCTS AND MEDICAL DEVICESArunpandiyan59
This document provides an overview of regulations for combination products and medical devices in the United States and India. It discusses what combination products are, examples of combination products, and the roles of the US FDA Office of Combination Products in classifying and assigning combination products for review. It also summarizes the regulatory requirements for medical devices in the US, including establishment registration, medical device listing, premarket notification, premarket approval, and quality system regulations. The latest developments in medical device regulation in India are also briefly outlined.
GCP Guideline published by Turkish Medicine and Medical Device AgencySerkan Kaçar
The document provides guidelines for Good Clinical Practices (GCP) in conducting clinical studies and trials involving human subjects. It outlines key definitions related to clinical research and trials, such as adverse events, informed consent, investigators, and ethics committees. It emphasizes that the rights, safety and well-being of clinical trial subjects are most important and should prevail over other interests. Clinical trials must be designed and conducted according to scientific and ethical standards to ensure quality and protection of subjects.
CLINICAL INVESTIGATION AND EVALUATION OF MEDICAL DEVICES AND.pptxFaizanShaikh204666
the presentation give idea about what is medical devices?
definition's given by cdsco and usfda
what is clinical investigation in evaluation in medical devices?
GMP Sub Part - "H" provide valuable information regarding holding and control of pharmaceutical goods, while Sub Part - "I" shows laboratory control and Sub Part - "J" give ideas about record and reports. Very helpful to pharma professionals.
Canadian policy for combination (drug / device) productsJasmin NUHIC
The purpose of this policy is to ensure timely access to drug/medical device combination products by
establishing a single window approach and more efficient submission processing system, while ensuring
that combination products marketed in Canada are safe, effective, and of high quality.
The document discusses the New Drug Application (NDA) process required by the FDA to approve new pharmaceutical drugs for sale and marketing in the United States. An NDA provides data from animal and human clinical trials to allow the FDA to determine if the drug is safe, effective and manufactured properly. It includes details on manufacturing, packaging, non-clinical and clinical testing results. If clinical trials confirm the drug's safety and effectiveness, manufacturers can file an NDA to request approval to produce and sell the drug. The NDA review process evaluates whether the drug's risks are outweighed by its benefits and whether labeling and quality controls are adequate.
This document summarizes key aspects of non-clinical drug development. It discusses how non-clinical studies are performed in silico, in vitro, and in vivo to assess safety, efficacy, pharmacokinetics, and manufacturing viability before human clinical trials. It also describes the Investigational New Drug application process which is required to begin clinical trials in humans, and provides an overview of the New Drug Application submitted for marketing approval. The document concludes by outlining the contents of an Investigational Medicinal Products Dossier which forms the basis for approval of multinational clinical trials in the European Union.
This Decree regulates the management of medical equipment, including: classification of medical equipment;
production, clinical research, circulation, purchase and sale, export, import, and service provision of medical equipment;
information, advertising medical equipment; price management of medical equipment and management and use of
medical equipment at medical facilities.
2 . This Decree does not apply to:
a ) Raw materials and semi-finished products for the production of medical equipment, except raw materials
containing narcotics and precursors;
b ) Raw materials for production of medical equipment are samples of blood, serum, plasma, urine, feces, human
body secretions, and other samples from humans, which must ensure biosafety when imported or exported. according to
regulations of the Law;
c ) Medical gas;
d ) Accessories used with medical equipment;
dd) Products used in medicine for research purposes (Research Use Only - RUO), products used in laboratories
(Laboratory Use Only - LUO).
This Decree regulates the management of medical equipment, including: classification of medical equipment;
production, clinical research, circulation, purchase and sale, export, import, and service provision of medical equipment;
information, advertising medical equipment; price management of medical equipment and management and use of
medical equipment at medical facilities.
2 . This Decree does not apply to:
a ) Raw materials and semi-finished products for the production of medical equipment, except raw materials
containing narcotics and precursors;
b ) Raw materials for production of medical equipment are samples of blood, serum, plasma, urine, feces, human
body secretions, and other samples from humans, which must ensure biosafety when imported or exported. according to
regulations of the Law;
c ) Medical gas;
d ) Accessories used with medical equipment;
dd) Products used in medicine for research purposes (Research Use Only - RUO), products used in laboratories
(Laboratory Use Only - LUO).
CFR 21 is the basic for pharmaceutical professionals who are working in regulatory market. Here I have presented part 211 as it is described in the guidance.
The document summarizes regulatory considerations for pharmaceuticals in Japan, including manufacturing, packaging, labeling, and post-marketing surveillance. For manufacturing, drugs must be approved by the Ministry of Health, Labor and Welfare and manufacturers must be licensed and follow good manufacturing practices. Packaging and labeling must contain specified information and any changes require relabeling. Post-marketing surveillance involves adverse event reporting, drug reexaminations every few years to reconfirm safety and efficacy, and reevaluations based on current medical knowledge.
The document provides information on Investigational New Drug (IND) enabling studies and the IND application process. Some key points:
- An IND application is required to ship an experimental drug across state lines for clinical trials before marketing approval. The FDA reviews the IND for safety.
- An IND application contains information on animal studies, chemistry/manufacturing, and clinical trial protocols. It must demonstrate the drug is reasonably safe for initial human testing.
- An IND application must follow specific guidelines, including summaries of pharmacology/toxicology studies, chemistry/manufacturing details, clinical protocols, and responsibilities of investigators and sponsors. It allows the drug to enter Phase I clinical trials upon
This document outlines requirements and guidelines for importing or manufacturing new drugs in India according to Drugs and Cosmetics Rules. It defines key terms like new drug, clinical trial, adverse events and reactions. It describes application procedures for new drug development and permissions under Form 44. Responsibilities of sponsors, investigators and ethics committees are provided. Important considerations for human clinical pharmacology, periodic safety update reports, label and carton drafting, and bioequivalence studies are highlighted.
Este documento discute as considerações regulatórias sobre produtos biológicos no Brasil. A Resolução RDC no 55 estabelece requisitos para o registro de produtos biológicos no país, incluindo duas vias regulatórias: uma via de desenvolvimento por comparabilidade e outra via de desenvolvimento individual. No entanto, a resolução não esclarece sobre a necessidade de estrutura molecular idêntica entre produtos biológicos similares e de referência, que é essencial segundo diretrizes da OMS para garantir qualidade,
Este documento discute las consideraciones regulatorias sobre productos biológicos en Brasil. Presenta datos sobre el gasto en salud en Brasil y la necesidad de mayor financiamiento público para cumplir con los estándares internacionales de acceso universal a la salud. También analiza la Resolución RDC No. 55 de 2010 de la agencia regulatoria brasileña ANVISA, la cual establece los requisitos para el registro de nuevos productos biológicos y productos biológicos similares. Finalmente, señala algunas preocupaciones con respecto
Este documento es el número 1 del volumen 148 de la revista Gaceta Médica de México, el órgano oficial de la Academia Nacional de Medicina de México. La revista incluye artículos sobre diabetes mellitus tipo 2 en personas mayores, factores de riesgo en la retinopatía del prematuro, mortalidad por cáncer cérvico-uterino y medicamentos biotecnológicos y biocomparables. Además, presenta la mesa directiva de la Academia Nacional de Medicina de México para el periodo 2011-2012.
This document provides guidelines on evaluating similar biological medicinal products. It outlines the regulatory framework and scope of such products. The key principles are:
1) Comparability studies are required to demonstrate similarity in quality, safety and efficacy between a new product and an authorized reference product.
2) The level of characterization required depends on the product's complexity, with highly purified products more readily characterized than others.
3) Whether a product can use the "similar biological" approach depends on available analytical procedures and manufacturing control, as well as clinical experience. Relevant guidelines are provided for specific types of biological products.
This draft guidance provides recommendations for demonstrating that a proposed therapeutic protein product is biosimilar to an FDA-licensed reference product. It discusses using a stepwise approach and totality-of-the-evidence to assess biosimilarity based on analytical, animal, and clinical studies comparing structure, function, toxicity, pharmacokinetics, immunogenicity, and safety and effectiveness. The guidance also addresses complexities of protein products and manufacturing considerations.
Denizar vianna clap_bio_meeting_rio_dec16th2011 [modo de compatibilidade]Clapbio
This document outlines the objectives of the Centro Latino Americano de Pesquisa em Biológicos (CLAPBio). CLAPBio aims to strengthen regulatory and economic decision making regarding biosimilars in Latin America through three main objectives: 1) Developing tools and training national teams, 2) Creating an economic model for biosimilars, and 3) Establishing collaborations across organizations in Latin American countries. Key activities include creating guidelines, conducting studies, providing technical support, and launching an online learning platform to disseminate information on biosimilars. The overall goal is to support informed and evidence-based decisions regarding biosimilar approval and adoption in the region.
16 12 11_sdm_concepts[2] [modo de compatibilidade]Clapbio
O documento discute a tomada de decisão compartilhada em saúde, definindo o conceito, questões prioritárias de pesquisa e como implementá-la na prática clínica, com foco no papel das ferramentas de apoio à decisão.
This document outlines regulations for controlling human pharmaceutical products in a national system. It establishes the Ministry of Health and the Institute of Public Health as the competent authorities responsible for regulating pharmaceutical activities including registration, manufacturing, distribution, and advertising. It also assigns responsibilities to Regional Health Departments for authorizing product admission and enforcing compliance. Finally, it provides definitions for 29 key terms related to pharmaceutical quality, safety, and regulation.
Who guidelines on evaluation of similar biotherapeutic products (sb ps) – spa...Clapbio
Este documento presenta lineamientos para la evaluación de productos bioterapéuticos similares (PBS) desarrollados por la Organización Mundial de la Salud. Explica que los PBS se basan parcialmente en la información clínica y no clínica del producto bioterapéutico de referencia original aprobado. Proporciona definiciones clave y principios para garantizar la calidad, seguridad y eficacia de los PBS a través de comparaciones con el producto de referencia. El objetivo es armonizar los requisitos globales
Este documento modifica el Capítulo V del Título II del Decreto Ejecutivo 178 de 2001 sobre el registro sanitario de productos biológicos y biotecnológicos en Panamá. Se añaden nuevas secciones que establecen los requisitos para la obtención del registro de productos biotecnológicos, incluyendo estudios clínicos y de comparación, programas de gestión de riesgos y planes de farmacovigilancia. También se especifican los detalles que deben incluirse en las monografías y etiquetas
Este documento propone una norma y aspectos técnicos para la evaluación de productos farmacéuticos biotecnológicos derivados de técnicas ADN recombinantes. Define términos clave como biosimilar, comparabilidad y estudios de comparabilidad. Explica que los biosimilares son medicamentos similares pero no idénticos a productos biotecnológicos innovadores cuya patente expiró. Debido a que los biosimilares son moléculas complejas producidas por procesos delicados, se requiere una normativa
El decreto reforma y adiciona diversas disposiciones del Reglamento de Insumos para la Salud para regular mejor los medicamentos biotecnológicos. Se definen términos como biofármaco, medicamento biotecnológico innovador y biocomparable. También se establecen nuevos requisitos para la fabricación, importación, etiquetado y receta de medicamentos biotecnológicos.
7075 11 iname establece requisitos para registro de especialidades medicina...Clapbio
La Unión Europea ha acordado un paquete de sanciones contra Rusia por su invasión de Ucrania. Las sanciones incluyen restricciones a los bancos rusos, la prohibición de exportaciones de alta tecnología a Rusia y la congelación de activos de oligarcas rusos. Los líderes de la UE esperan que estas medidas disuadan a Rusia de continuar su agresión militar contra Ucrania.
Technical note about biological products 19 10 11Clapbio
The document discusses Brazil's interest in promoting domestic production of biotechnological products as patents expire globally. It outlines Brazil's regulatory framework for approving biologics, including two pathways for approving non-innovative copies based on comparability studies. Recent regulatory changes aim to provide guidelines supporting domestic development of biologic copies while ensuring safety and efficacy.
This document establishes new regulations for the registration of biological medicinal products in Argentina. It defines biological products and outlines specific requirements and procedures for their registration, including information that must be included in registration certificates. Evaluation and approval of registration applications will ensure biological products have favorable benefit-risk ratios, sufficient therapeutic efficacy, adequate quality and composition supported by application materials.
Este documento fornece orientações sobre como realizar o exercício de comparabilidade para registro de produtos biológicos pela Agência Nacional de Vigilância Sanitária do Brasil (Anvisa). O guia aborda os requisitos de qualidade, estabilidade, processo de fabricação e determinação da similaridade entre o produto biológico e o produto biológico comparador. O objetivo é garantir que o produto biológico tenha atributos altamente semelhantes ao produto comparador para que possa ser registrado com menos dados clínicos e não cl
Este documento fornece diretrizes para a elaboração de relatórios clínicos para fins de registro e alterações pós-registro de produtos biológicos. Ele abrange os seguintes tópicos: 1) introdução geral; 2) ética; 3) objetivos do estudo; 4) plano de investigação; 5) tratamentos; 6) randomização e mascaramento; 7) desfechos de eficácia e segurança; 8) métodos estatísticos; 9) sujeitos de pesquisa; 10) avaliação da eficácia;
Este documento fornece orientações para a realização de estudos não clínicos e clínicos para o registro de alfainterferona humana recombinante utilizando a via de desenvolvimento por comparabilidade. É recomendada a realização de estudos farmacocinéticos, farmacodinâmicos e de toxicidade comparativos em modelos não clínicos e um estudo clínico de fase I comparativo em voluntários saudáveis. Além disso, um estudo clínico de fase II/III comparativo é sugerido para avaliar a efic
1. O guia estabelece as exigências clínicas e não-clínicas para o registro de heparinas na Anvisa utilizando a via de desenvolvimento por comparabilidade.
2. Nos estudos não-clínicos, deve-se comparar a atividade farmacodinâmica e a toxicidade da heparina em teste e do produto comparador em modelos in vitro e in vivo.
3. Nos estudos clínicos, as propriedades farmacocinéticas/farmacodinâmicas devem ser comparadas em um estudo randomizado e
1) O documento fornece diretrizes para o desenvolvimento e avaliação de produtos bioterápicos similares (PBSs).
2) PBSs são produtos biológicos projetados para serem similares a um produto bioterápico original licenciado, mas requerem sua própria avaliação de qualidade, segurança e eficácia.
3) As diretrizes abordam questões de qualidade, avaliação não-clínica e clínica necessárias para o licenciamento de PBSs de forma a garantir níveis aceitáveis de qualidade
NIMA2024 | De toegevoegde waarde van DEI en ESG in campagnes | Nathalie Lam |...BBPMedia1
Nathalie zal delen hoe DEI en ESG een fundamentele rol kunnen spelen in je merkstrategie en je de juiste aansluiting kan creëren met je doelgroep. Door middel van voorbeelden en simpele handvatten toont ze hoe dit in jouw organisatie toegepast kan worden.
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This presentation is a curated compilation of PowerPoint diagrams and templates designed to illustrate 20 different digital transformation frameworks and models. These frameworks are based on recent industry trends and best practices, ensuring that the content remains relevant and up-to-date.
Key highlights include Microsoft's Digital Transformation Framework, which focuses on driving innovation and efficiency, and McKinsey's Ten Guiding Principles, which provide strategic insights for successful digital transformation. Additionally, Forrester's framework emphasizes enhancing customer experiences and modernizing IT infrastructure, while IDC's MaturityScape helps assess and develop organizational digital maturity. MIT's framework explores cutting-edge strategies for achieving digital success.
These materials are perfect for enhancing your business or classroom presentations, offering visual aids to supplement your insights. Please note that while comprehensive, these slides are intended as supplementary resources and may not be complete for standalone instructional purposes.
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Capgemini’s Digital Transformation Framework
PwC’s Digital Transformation Framework
Cisco’s Digital Transformation Framework
Cognizant’s Digital Transformation Framework
DXC Technology’s Digital Transformation Framework
The BCG Strategy Palette
McKinsey’s Digital Transformation Framework
Digital Transformation Compass
Four Levels of Digital Maturity
Design Thinking Framework
Business Model Canvas
Customer Journey Map
Garments ERP Software in Bangladesh _ Pridesys IT Ltd.pdfPridesys IT Ltd.
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Presentation by Herman Kienhuis (Curiosity VC) on Investing in AI for ABS Alu...Herman Kienhuis
Presentation by Herman Kienhuis (Curiosity VC) on developments in AI, the venture capital investment landscape and Curiosity VC's approach to investing, at the alumni event of Amsterdam Business School (University of Amsterdam) on June 13, 2024 in Amsterdam.
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1. REGULATIONS OF THE NATIONAL SYSTEM FOR THE CONTROL OF
HUMAN PHARMACEUTICAL PRODUCTS
PRELIMINARY CHAPTER
SCOPE AND COMPETENT AUTHORITIES
ARTICLE 1 - These regulations include technical and administrative standards and other terms or
conditions to be met for registering, importing, exporting, manufacturing, storing, possessing, and
distributing (either free or for good and valuable consideration) pharmaceutical products, for
advertising and/or supplying information about them, and for their use for scientific research.
ARTICLE 2 - The Ministry of Health, through the Department of Public Health, shall be required to
play a guiding and regulatory role in the field of pharmaceutical products, implementing a national
drug policy and issuing technical and administrative standards to be met by public and private
entities engaging in the activities outlined in the previous article and which shall be approved by
relevant administrative acts.
ARTICLE 3 - The Institute of Public Health is the national health authority responsible for the
sanitary surveillance of pharmaceutical products and for ensuring compliance with the provisions
set forth herein, the Sanitary Code and its supplementary regulations, and other laws on the
subject.
The Institute is furthermore responsible for verifying the quality of pharmaceutical products in any
of the stages referred to in article 1; authorizing the installation and operation of pharmaceutical
laboratories; licensing and registering pharmaceuticals and other products subject to these forms
of control; supervising conditions for import, admission, export, manufacturing, and distribution of
this products, and likewise any advertising and information about the same; controlling drugs and
pharmaceutical products that cause addiction, and other psychotropic substances likely to have a
similar effect, in relation to the import, export, and lawful use thereof in the preparation of
pharmaceutical products; and monitoring compliance with the provisions hereunder and other
regulations governing such matters.
ARTICLE 4 - The Regional Health Departments shall be responsible for authorizing the admission of
pharmaceutical products according to the provisions set forth in article 2 of law no. 18,164. In
addition, Regional Health Departments shall be required to enforce and monitor the compliance
with the provisions herein regarding the distribution, storage, and possession of pharmaceutical
products, insofar as these activities are carried out by authorized pharmaceutical facilities, except
for pharmaceutical laboratories.
ARTICLE 5 - For the purposes hereof, the definitions below shall be construed and interpreted as
follows:
1
2. 1) Biological activity: Measurable response of in vivo or in vitro activity or potency
characterizing a certain amount of a pharmaceutical product with respect to a
reference standard.
2) Administration: The act whereby a drug comes into contact with humans, so that a
local or systemic action may be exerted upon absorption thereof.
3) Quality assurance: A comprehensive system designed to ensure that the processes
and their results meet certain quality requirements previously set out.
4) Bioavailability: The amount of an active ingredient from a pharmaceutical form that
reaches the systemic circulation and the speed at which this occurs.
5) Good Laboratory Practice (GLP): A set of rules, operating procedures and practices to
ensure that the data generated by a quality control system is reproducible and
representative, and to guarantee the validity and reliability of such results. Said
technical standards shall be required to be approved by order of the Ministry at the
proposal of the Institute.
6) Good Manufacturing Practice (GMP): Minimum technical standards established for all
procedures with a view to ensure a constant and satisfactory quality in pharmaceutical
products within statutory limits currently in force. Said standards shall be required to
be approved by order of the Ministry at the proposal of the Institute.
7) Drug quantity: Appropriateness of the drug for the use for which it is intended as
determined by its efficacy, safety, and stability, according to its identity, strength,
purity, and others features in accordance with the relevant sanitary registration.
8) Sanitary registration certificate: A document issued by the health authority of the
country of origin or manufacture upon request of the interested party, stating that:
The manufacturing facilities meet the conditions required by sanitary
legislation in the relevant country for the manufacture and packaging of the
registered product.
The product is registered in the country issuing the certificate in accordance
with current regulations, indicating the authorized formula in full detail.
The sale or distribution of the product under any conditions is subject to a
restrictive regime or other special sanitary supervision, if applicable.
9) Quality control: Activities aimed at ensuring the uniformity of product batches at all
manufacturing stages in accordance with identity, strength, purity, and other quality
requirements set out in the respective monograph and authorized in the
corresponding sanitary registration.
10) Shelf control: Product quality checking during retail and distribution to the public
conducted by the Institute or an appointed health authority in accordance with
programmes developed by the Ministry at the proposal of the Institute.
11) Code: Distinctive alphanumeric or numeric combination which makes it possible to
identify a pharmaceutical product unambiguously during its manufacture, storage,
distribution and retail for the purposes of ensuring the traceability thereof.
12) Counter-sample: A limited sample of analyzed products that is kept under the same
conditions as reference samples.
2
3. 13) Quarantine: A transitional period of physical or other type of isolation of raw
materials, materials in any shape or form, and intermediate, semi-manufactured, bulk,
semi-finished or finished products during which their use or distribution is forbidden
while a decision is reached on their release, rejection or reprocessing, in the light of
the results of the respective quality control.
14) Dispensation: The act whereby the professional pharmaceutical chemist supplies a
drug to a person, usually following the prescription of an authorized practitioner, and
provides guidance on its use, influence of food, drug interactions, potential adverse
reactions, storage conditions and other relevant information, as authorized in the
corresponding registration.
15) Distribution: Delivery of the pharmaceutical product to manufacturing facilities,
importers, distributors or other authorized agents.
16) Dosage: The administration interval and period of treatment provided for the dose of
a drug or a pharmaceutical product.
17) Dose: The total amount of a drug or pharmaceutical product in the approved dosage
form administered each time.
18) Plant drug or material: Plant or raw parts thereof used for medicinal or
pharmaceutical purposes.
19) Effectiveness: The capacity of a drug or pharmaceutical product to produce the
desired therapeutic effect as determined by scientific methods and clinical trials in
humans.
20) Insert: Sleeve made of cardboard or other material that protects the blister or strip
and contains the patient information leaflet and/or the authorized graphic label.
21) Dissolution assay: In vitro test performed under predefined experimental conditions
for determining the dissolution rate of a solid active ingredient from a pharmaceutical
form.
22) Dispenser: A package intended for retail of pharmaceutical products authorized for
sale in blisters, strips, envelopes, protective inserts, or other primary packaging
protective systems under the conditions established in the registration.
23) Primary packaging: A material used to hold and envelop pharmaceutical products in
their final pharmaceutical form.
24) Secondary packaging: A tamper-resistant container that holds and protects the
primary packaging.
25) Clinical packaging: A package intended for use only in pharmacies or with medical kits
at healthcare facilities that is supplied or delivered to patients according to the
prescribed dosage and form.
26) Pharmaceutical equivalents: Pharmaceutical products containing identical amounts of
the same active ingredients or salts or esters thereof and having the same
pharmaceutical form and route of administration, but not necessarily the same
excipients, and meet the same or similar quality specifications .
27) Therapeutic equivalents: Pharmaceutical equivalents meeting the same or similar
quality specifications and producing essentially the same effects upon administration
3
4. under conditions described in their labels insofar as potency and effectiveness are
concerned as determined by appropriate tests.
28) Pharmaceutical drug: Registered pharmaceutical product having a distinctive
packaging adapted for its use and designated under a generic name or other
designation. It shall be construed as including elements or devices for its
administration where appropriate.
29) Specifications: Technical document defining the characteristics of a raw material,
material, product, or service and determining which variables should be assessed in
them, further describing the tests, assays and analyses used to determine them and
establishing the criteria for acceptance or rejection.
30) Stability: The capacity of an active ingredient or a finished pharmaceutical product to
keep its original properties according to the specifications set forth and authorized in
their monograph, which guarantees its physical, chemical, biological and
microbiological properties, as appropriate, within specified limits throughout the
effectiveness period.
31) Manufacturing status: The status of a pharmaceutical product within the
manufacturing process (semi-manufactured, bulk, semi-finished or finished).
32) Therapeutic equivalence study: A comparative clinical, bioavailability,
pharmacodynamic or “in vitro” test performed on a reference pharmaceutical product
and another one under evaluation.
33) Real-time stability study: A stability test carried out for the time of the effectiveness
period and under storage, temperature, and humidity conditions determined by the
nature of the product.
34) Accelerated stability study: A stability test designed to increase the speed of chemical
degradation or the physical changes of an active ingredient or a pharmaceutical
product in its primary packaging under severe storage, temperature, and humidity
conditions as part of a formal storage programme for a certain period of time
according to the active ingredient under evaluation, resulting in the determination of
stability for a certain period.
35) Stability study: A series of tests, assays and analyses relating to the physical, chemical,
biological, and microbiological characteristics of an active ingredient or a
pharmaceutical product conducted for the purposes of gathering information about its
stability in order to determine the effectiveness period under certain packaging and
storage conditions.
36) Bioavailability studies: Pharmacokinetic tests following a predefined experimental
design which make it possible to determine the bioavailability of an active ingredient.
37) Pharmacokinetic studies: In vivo assays following a predefined experimental design to
help establish the kinetics of the absorption, distribution, excretion, and metabolic
processes of the active ingredients and metabolites of a pharmaceutical product.
38) Evaluation of a pharmaceutical product: Systematic study of information provided by
the interested party requesting a sanitary registration with respect to the relevance of
administrative and technical records such as pharmaceutical, pharmacological,
4
5. toxicological, clinical, and therapeutic properties in order to determine or certify
whether the product is suitable for the prescribed use.
39) Excipient: Any material used in the manufacture of the products described herein
other than an active ingredient.
40) Retailing: Retail sale of a pharmaceutical product to users or consumers.
41) Pharmacovigilance: A set of activities concerned with the detection, evaluation,
understanding, and prevention of adverse effects associated with the use of drugs.
42) Expiry date: The date as indicated by the month and year, and in some cases the day,
according to the relevant sanitary registration, beyond which the product cannot be
expected to remain stable.
43) Pharmaceutical form: Physical form of a drug to facilitate its fractionation,
dispensation, dosage and administration, or use.
44) Master pattern or formula: A document or set of documents indicating raw materials,
amounts, packaging materials, and a description of the procedures and precautions
for producing a specific amount of a finished product, further indicating
manufacturing instructions and process controls.
45) Import: The act whereby a foreign pharmaceutical product enters the country and is
admitted for distribution in compliance with current regulations.
46) Impurity: Any component not defined as constituting the raw material or product.
47) Admission: The act whereby a foreign pharmaceutical product is placed in a duly
authorized storage site pending approval for distribution and use.
48) License: Power of attorney or authorization lawfully granted by an individual or legal
entity to request, amend or cancel a sanitary registration.
49) Plant markers: Chemically defined constituents of the plant active ingredients of
relevance for quality control purposes, regardless of whether they have therapeutic
activity and can be used to calculate the amount of the plant active ingredients in the
final product, provided they have been quantified in the plant preparation or drug
used as raw material in the preparation.
50) Tolerance margins: Officially authorized percentages and maximum and minimum
amount of an active ingredient in a product.
51) Raw material: Any substance of a particular quality directly involved in the
manufacture of the pharmaceutical form, whether it remains unchanged or is
modified or removed during the manufacturing process.
52) Packaging material: Material used for a primary packaging, a secondary packaging, or
an insert.
53) Monograph: A document containing the technical, pharmaceutical, and scientific
description of the characteristics and properties of a product.
54) Medical sample: A unit of a pharmaceutical drug for free distribution only to legally-
qualified prescribing professionals having the same labelling of the registered product
and indicating its status as a medical sample, which may include further information
for healthcare professionals.
5
6. 55) Reference samples: Samples taken from each batch of finished product that are
required to be kept for one year after the expiry date of the product in their final
packaging and stored under conditions specified in the sanitary registration.
56) Legal sample or counter-sample: A sample taken by the relevant health authority in
its supervisory capacity, registered in a certificate and under chain-of-custody
conditions.
57) Generic name for a pharmaceutical product: A name accepted by the World Health
Organization (WHO) under the International Non-proprietary Names (INN) system or
otherwise in the pharmacopoeias officially recognized in the country.
58) Country of origin: The country from which a pharmaceutical product has been shipped
for importation into Chile, regardless of any territories through which it travels.
59) Manufacturing country: The country where the manufacturing facilities of a
pharmaceutical product are located, with respect to any of the steps required to
obtain a finished product.
60) Effectiveness period: A period as authorized by the Institute in the relevant sanitary
registration during which a product is required to remain stable under the packaging
and storage conditions set out in the corresponding stability study.
61) Potency: Therapeutic activity of a pharmaceutical product for producing a particular
effect endorsed by appropriate laboratory tests or controlled clinical data obtained by
administering the product under the recommended and authorized conditions of use
as prescribed in accordance with the concentration of active ingredients in the
product formula expressed in weight/weight, weight/volume, unit dose/volume, or
any other units referring to an internationally recognized standard.
62) Plant preparation: A pulverized plant or parts thereof, extracts, dyes, squeezed juice,
fatty or essential oils, gums or other product from a particular process, excluding
chemically defined isolated constituents or mixtures thereof, subject to the possibility
that they may contain other components such as solvents, diluents or preservatives
which shall be required to be declared.
63) Active ingredient: A substance or mixture of substances causing a particular
pharmacological effect or having the capacity to cause such an effect upon
administration.
64) Standard operating procedure (SOP): A written document providing updated
instructions numbered in a logical and continuous sequence to perform general
operations not necessarily confined to a particular product or material, which should
be developed, reviewed and updated by competent authorized staff in order to be
followed by technical professionals in charge of the facilities where they are
implemented with a view to draw up additional documentation on manufacturing
processes and for the purposes of quality assurance and control.
65) Bulk product: A product in its final pharmaceutical form.
66) Associated pharmaceutical product: A product comprising two or more active
ingredients in a single pharmaceutical form.
6
7. 67) Combined pharmaceutical product: A product made of two or more pharmaceutical
products included in a single package to be administered sequentially or
simultaneously.
68) Reference pharmaceutical product: A product defined as such by health authorities in
respect of which another requiring a therapeutic equivalence evaluation is compared.
69) Semi-manufactured product: A substance or mixture of partially processed
substances preceding the pharmaceutical form and requiring further manufacturing
steps.
70) Semi-finished product: A product in its final pharmaceutical form and primary
packaging.
71) Finished product: A product in its final packaging, labelled and ready for distribution.
72) Production, production process or manufacture: A set of operations for obtaining a
pharmaceutical product, from the purchase and receipt of materials to the release,
storage and quality control thereof.
73) Adverse drug reaction (ADR): A noxious and unintended reaction occurring at doses
normally used in humans.
74) Serious adverse reaction: An adverse reaction that is fatal or likely to endanger life, or
involving serious disability or incapacity, or that has resulted in hospitalization or its
extension.
75) Unexpected adverse reaction: An adverse reaction undisclosed in the product
monograph or the patient information leaflets, or unknown to the authorized
prescribing professional.
76) Prescription: An order signed by a legally qualified professional so that an amount of
one or more drugs is supplied and administered as indicated.
77) Sanitary registration: The process of evaluation of a pharmaceutical product resulting
in a registration under sequential numbering on a special list held by the Institute prior
to its distribution and use.
78) Graphic label: A graphic representation displaying the officially authorized text in
accordance with the relevant sanitary registration for different types of approved
packaging as appropriate.
79) Batch: A certain amount of raw material, packaging material or processed product
resulting from a single production cycle or continuous steps characterized by its
homogeneity.
80) Sub-batch: A specific and identified fraction of a batch.
81) Possession: The ownership of a pharmaceutical product by an individual or a legal
entity either having the corresponding deed or not.
82) Holder of a sanitary registration: A national or foreign individual or legal entity
domiciled in Chile whose name appears on a sanitary registration.
83) Traceability of analytical data: Features or characteristics of the result of a
measurement or the value of a standard related to specific references, usually
national or international standards, across an unbroken chain of comparisons with
specified uncertainties.
7
8. 84) Traceability of a product: The ability to trace a specific unit of a product along any
stage of the manufacturing process and/or a batch along the distribution chain and
across different relevant entities until it is supplied, administrated or used.
85) Unit of sale: An authorized retail presentation for supply and sale.
86) Validation: A documented action performed in accordance with the principles of Good
Manufacturing and Laboratory Practice with a view to demonstrate that the
procedures, processes, activities or systems used during the manufacture and quality
control of a product are conducive to the results indicated within the established
limits.
ARTICLE 6 - The manufacture, importation, possession, distribution and transfer of pharmaceutical
products for any purpose is prohibited under the following circumstances:
1. Contaminated pharmaceutical product: A product containing microorganisms,
parasites or parts thereof capable of causing diseases in humans, or unauthorized
amounts of potentially toxic, carcinogenic or mutagenic substances or other foreign
materials.
2. Altered pharmaceutical product: A finished product which due to inadequate storage,
transportation, preservation or any other reason after being manufactured:
a. has decreased its activity below the limits indicated in the sanitary
registration, or in the case of raw materials, in quality specifications according
to official texts;
b. has lost effectiveness or undergone changes affecting its quality;
c. is in a damaged packaging, or
d. is distributed or sold after the effectiveness period.
3. Adulterated pharmaceutical product: A product whose composition, specifications or
other conditions indicated in the corresponding sanitary registration, or in the case of
raw materials, in quality specifications according to official texts, have been modified
without permission or compliance with said specifications.
4. Counterfeit pharmaceutical product: An unregistered or unlicensed pharmaceutical
product manufactured or imported without prior sanitary authorization. Additionally,
the foregoing definition shall be construed as including counterfeit products
distributed or sold without authorization.
The Institute shall be required to monitor the existence of such pharmaceutical products and
adopt any sanitary measures or impose the corresponding penalties upon conducting a prior
preliminary investigation.
The Regional Health Departments shall be required to monitor the retail and supply of products
under the conditions described above.
The Regional Health Departments shall additionally be required to inform the Institute of any
findings concerning the conditions described in the preceding paragraph so that the Institute can
adopt the necessary measures or conduct investigations with respect to holders of sanitary
registrations, manufacturers, importers or distributors as appropriate.
8
9. Furthermore, the Institute or the Regional Health Departments shall be required to lodge the
corresponding complaint with the Public Prosecutor's Office with a view to conduct an
investigation and impose criminal liabilities if applicable.
CHAPTER I
PHARMACEUTICAL PRODUCTS
SECTION 1
DEFINITION
ARTICLE 7 - A pharmaceutical product or drug is any natural or synthetic substance, or mixtures
thereof, intended for use in humans in the cure, mitigation, treatment, prevention or diagnosis of
diseases or their symptoms, or for producing changes in the physiological system or mental state
of the individual to whom it is administered.
Pharmaceutical products shall be construed as including active raw materials, pharmaceutical
preparations, pharmaceutical drugs and traditional herbal medicines.
ARTICLE 8 - Based on substantiated decisions, the Institute shall impose an appropriate regulatory
regime on all products having or described as having some of the properties listed in the previous
article and labelled or advertised as food items. The decisions made by the Institute shall be
binding both on products currently in the market as well as those distributed and sold for the first
time.
The determination of the applicable regulatory regime may be made either ex officio or at the
request of individuals or other public organizations upon detecting products under the conditions
mentioned in the preceding paragraph in their capacity as supervisory bodies.
For the purposes of determining the applicable regulatory regime as requested, the Regional
Health Departments shall be required to submit a technical report and copies of all records in their
possession, as well as results from inspections and audits if applicable.
Should the Institute establish that the applicable regulatory regime corresponds to a
pharmaceutical product, the corresponding formal resolution shall be required to be published in
the Official Gazette and a notice shall be served on the interested party for the purposes of
requesting a sanitary registration by providing relevant information for all products comprising
components with the alleged therapeutic activity.
Upon service of the aforementioned notice and prior to obtaining a sanitary registration, the
pharmaceutical product shall be recalled by the distributor or retailer, without prejudice to further
sanitary liabilities. These provisions shall also apply for other products comprising the ingredients
of the pharmaceutical product.
In the event of the Institute finding that the applicable regulatory regime does not correspond to a
pharmaceutical product, the records shall be required to be submitted to the Ministry for review
along with a technical report explaining the reasons behind the decision.
ARTICLE 9 - In addition, the determination of the applicable regulatory regime may be made when
9
10. in doubt about the classification of other products such as cosmetics, household and sanitary
pesticides, or medical devices, following the same procedure outlined above.
SECTION 2
PHARMACEUTICAL DRUGS AND THEIR CLASSIFICATION
ARTICLE 10 - According to their nature, pharmaceutical drugs are classified as:
a) chemical products;
b) biological products;
c) radiopharmaceuticals;
d) phytopharmaceuticals;
e) homeopathic products;
f) medical gases; and
g) other drugs not listed above.
ARTICLE 11 - Chemical products are drugs comprising one or more purified and identified active
ingredients obtained from a chemical synthesis or extraction process.
ARTICLE 12 - Biological products are obtained from and/or produced by living organisms and their
fluids or tissues.
Biological products are classified as follows:
a) Vaccines: Biological products formulated to stimulate active immunity.
b) Serum: Biological product formulated to develop passive immunity.
c) Blood products: Human blood or plasma biological derivatives obtained from
industrial processes using human blood or plasma as raw materials. Specifically, these
drugs include albumin, clotting factors and human immunoglobulin, except for human
whole blood, plasma and blood cells.
d) Hormones: Natural biological products like proteins, amino acid derivatives, spheroids
or lipids used to treat some disorders either by increasing or decreasing their levels.
Synthetic hormones are classified as synthetic products under article 10.a.
e) Biotechnological or recombinant drugs: Genetically engineered protein-like biological
products obtained from the combination of recombinant nucleic acids (DNA and RNA)
and monoclonal antibodies, among others.
f) Antibiotics: Biological products made of substances secreted by a microorganism with
antimicrobial capacity. Synthetic antibiotics are classified as synthetic products under
article 10.a.
g) Allergen: Biological product for identifying or introducing a specific and acquired
modification of the immunological response to an allergenic agent.
h) Gene therapy: Biological product obtained by means of a set of processes for the in
vivo or ex vivo transfer of prophylactic, diagnostic or therapeutic genes (DNA or RNA)
to human and animal cells and their subsequent expression in vivo.
10
11. ARTICLE 13 - Radiopharmaceuticals are products or formulations labelled with radionuclides or
radioisotopes for use in the diagnosis or treatment of diseases, regardless of the route of
administration.
ARTICLE 14 - Phytopharmaceuticals are pharmaceutical drugs comprising standardized active
ingredients from aerial or underground parts of plants or other plant material.
ARTICLE 15 - Homeopathic products are pharmaceutical drugs comprising homeopathic
substances made of plant, animal, mineral or chemical raw materials prepared in accordance with
a homeopathic manufacturing procedure described in official regulations approved by order of the
Ministry necessarily including the processes of dilution and dynamization of mother dyes.
Homeopathic products shall be required to have been tested in healthy individuals and
repertorized for prescription or use according to the law of similars. A homeopathic product may
contain one or more homeopathic substances.
ARTICLE 16 - Medical gases are pharmaceutical drugs made of one or more gaseous components
of known concentration and impurity manufactured according to registered specifications and
intended for administration to humans. Such drugs shall be governed by specific regulations.
ARTICLE 17 - In addition to the aforementioned groups, pharmaceutical drugs include any other
products having therapeutic properties as indicated in the label, advertised or attributed by any
means, whether curative or for the mitigation, treatment, diagnosis or prevention of diseases or
their symptoms, or for changing physiological systems or mental states for the benefit of the
person to whom it is administered, and which are not classifiable under any of the above
categories.
This group includes the following:
a) Products for parenteral administration products, regardless of their properties or
effects.
b) Vitamins, minerals and other nutrients in therapeutic doses as determined in the
respective technical standard approved by order of the Ministry.
c) Animal or mineral products, as well as those comprising plant drugs and preparations
in association with active ingredients of different nature.
CHAPTER II
SANITARY REGISTRATION OF PHARMACEUTICAL DRUGS
AND OTHER PHARMACEUTICAL PRODUCTS
SECTION 1
CONCEPT AND PURPOSES
ARTICLE 18 - The sanitary registration of a pharmaceutical drug is a process of evaluation and
systematic study of its pharmaceutical, pharmacological, toxicological, and clinical properties with
11
12. a view to verify its quality, safety and efficacy, resulting in a registration under sequential
numbering on a special list held by the Institute prior to its distribution and use in the country.
The sanitary registration of a pharmaceutical product does not release the holder from the
obligation to comply with other laws or regulations governing the marketing of such products.
The sanitary registration may be requested by any national or foreign individual or legal entity duly
represented and domiciled in Chile.
ARTICLE 19 - The administrative proceedings concerning the sanitary registration are unrelated to
other commercial or intellectual property aspects as provided for in article 49 of the Industrial
Property Act, in accordance with the consolidated and coordinated text of law-ranking decree No.
3 of 2006 by the Ministry of Economy, Development and Reconstruction.
ARTICLE 20 - No pharmaceutical product, whether imported or manufactured in the country, shall
be distributed or used without prior sanitary registration.
ARTICLE 21 – Under exceptional circumstances, the Institute may authorize the sale or provisional
use of certain pharmaceutical products without the corresponding sanitary registration in view of
the provisions of article 102 of the Sanitary Code including but not limited to the following
circumstances:
a) Epidemics, emergency situations or disasters that may pose a serious risk to the health
or life of the population.
b) In the case of a pharmaceutical product that is required for urgent medical purposes
without there being any other alternative at such time.
c) In the case of products for use in scientific research or clinical trials, following a
favourable report from the relevant ethic committees in accordance with regulations
on clinical trials in humans approved by the Ministry of Health.
ARTICLE 22 - Applications submitted by interested parties for the sale or temporary use of
pharmaceutical products without prior sanitary registration based on a) and b) above shall require
prior authorization granted by the authorities of the country of origin or manufacturing country as
appropriate. In both cases, the authorizations granted to interested parties may be requested for a
second time within six months, upon receipt of the sanitary registration application or proof that
there is still urgent need for the drug, or that the emergency situations mentioned in the
preceding article remain unchanged.
ARTICLE 23 - Applications for provisional use of a pharmaceutical product in scientific research or
clinical trials shall be required to include a protocol approved by the ethics committee as set forth
in article 21.c, which shall also be required in the case of a registered product intended for a
different use other than as authorized.
ARTICLE 24 - Under the collaboration agreements by and between the Institute and the Regional
Health Departments of regions having customs offices pursuant to the provisions of the
12
13. Constitutional Law of State Administration (law no. 18,575) as consolidated and coordinated by
law-ranking decree No. 1 of 2000 by the General Secretariat of the Presidency, the Regional Health
Departments may authorize the temporary use of pharmaceutical products without prior
registration when they have been imported for personal use directly by the applicant or his
representative, provided that they are prescribed by a qualified healthcare professional stating the
need for the treatment and its duration.
Additionally, Regional Health Departments may authorize the admission of drugs by national or
foreign individuals carrying them upon entering the country for treatment for a period not
exceeding three weeks, except in the case of chronic diseases or other therapies, upon providing
the corresponding justification. Any drugs in excess shall be withheld for later confiscation.
Regional Health Departments shall be required to give the Institute a monthly notification of the
authorizations granted pursuant to this article.
ARTICLE 25 - For the purposes of article 102 of the Sanitary Code, pharmaceutical preparations
shall have an official sanitary registration number also appearing in the Official Preparations
Register which shall be deemed the official record of the Institute of Public Health.
ARTICLE 26 - Active starting materials comprising natural or synthetic bulk drugs shall be deemed
to be registered by the fact of being included in the formula of a registered pharmaceutical
product or by the respective authorization for use thereof when such materials are imported by
authorized businesses.
ARTICLE 27 - Traditional herbal medicines are made of plants or whole or crushed parts thereof,
either fresh or dried, hand packed and labelled, designated as is customary in accordance with
local cultural traditions, and recognized in the corresponding technical standard approved by
order of the Ministry as mentioned in the following paragraph. These drugs shall be deemed to be
registered for retail and distribution purposes upon authorization by the relevant Regional Health
Department of the facilities where they are stored, manufactured, packed or fractionated, or
which perform other processing activities, on the following conditions:
a) They shall be required to be listed under a technical standard issued by the Ministry and
approved by a decision adopted in its legal, technical, and administrative capacity,
indicating the name, therapeutic properties and uses thereof as symptomatic aids.
b) They shall be required to be hand-packed as isolated and unmixed plant species.
c) Reference must be made in the label only to those properties established in the
aforementioned decree.
SECTION 2
SANITARY REGISTRATION REQUIREMENTS
ARTICLE 28 - Sanitary registration applications shall be required to be submitted to the Institute in
compliance with the requirements set forth herein.
13
14. General registration requirements include administrative aspects as well as others relating to the
technical information, pharmaceutical quality, safety and clinical efficacy of the pharmaceutical
product; other special requirements depend on the nature of the product, and the healthcare
professional signing the application shall be responsible both for their origin and veracity.
1. Sanitary registration general requirements
A. Administrative requirements
ARTICLE 29 - A sanitary registration application shall be required to meet the following general
administrative requirements and include the following information:
1. Identification and address of the applicant and legal representative in the case of legal
entities.
2. Name of the chief technical officer in charge of the entity requesting the registration
or, if not applicable, of the professional responsible for the technical information
provided.
3. Name of the pharmaceutical product including:
a) trade name, generic or common international name, or otherwise the
pharmacopoeial or chemical name;
b) pharmaceutical form;
c) unit dose per pharmaceutical form; and
d) route of administration.
4. Class or therapeutic group, further indicating the corresponding anatomical-
therapeutic classification.
5. Manufacturing system, including:
a) domestic manufacture, for products manufactured in a legally and technically
qualified pharmaceutical laboratory, whether made at its own premises or by
third parties, or;
b) imported products, including:
i. imported finished products manufactured abroad, whether imported
directly or by authorized third parties;
ii. imported semi-finished products in their final primary packaging to be
fitted in Chile, either directly or by authorized third parties;
iii. imported bulk products in their final pharmaceutical form to be
packed in Chile, either directly or by authorized third parties;
iv. imported semi-manufactured products to engage in other subsequent
manufacturing activities in Chile necessary to obtain a finished
product, either directly or by authorized third parties.
6. Identification of the licensor under the name appearing on the license, if the license is
used for prosecution of the registration.
7. Name and address of the domestic or foreign manufacturing facility.
14
15. 8. Product presentation describing the contents of different packages, retail, clinical
packages and/or medical samples, including elements or devices used for the
administration thereof.
9. Physical description of the packaging material, indicating the type of primary and
secondary packaging materials and other elements or devices used for administration,
if applicable.
10. Legal documents in Spanish or translated versions there of signed by the legal
representative, an appointed professional or the chief technical officer of the
company including the following:
a) For products imported during any stage of the production process:
i. Sanitary registration certificate, pharmaceutical product certificate,
sanitary authorization certificate or official certification recommended
by the World Health Organization, issued by the authorities of the
country of origin and duly legalized, certifying that the manufacturing
facilities meet the requirements established in the sanitary legislation
of their country, that the product is registered in the country
according to current regulations (stating the approved formula in full),
and whether the sale of the product is subject to a restrictive regime
or special sanitary supervision, if applicable.
ii. Legalized manufacturing agreement signed by the applicant and the
foreign manufacturing pharmaceutical laboratory.
iii. Legalized license, if applicable.
iv. Official certificate issued by the competent health authority of the
country where the manufacturing facilities are located certifying that
the foreign manufacturer is duly authorized in their country and
follows Good Manufacturing Practices in accordance with WHO
recommendations, indicating production areas or types of products
authorized for manufacture, unless such information is included in the
document mentioned in a.i herein.
v. Legalized import agreement executed before a notary public, if
applicable.
vi. Manufacturing and/or domestic distribution agreement executed
before a notary public, attaching the corresponding sanitary
authorization for each facility.
vii. Quality control agreement entered into with a pharmaceutical
laboratory authorized by the Institute and executed before a notary
public, if applicable.
b) For domestically manufactured products:
i. Manufacturing and/or domestic distribution agreement executed
before a notary public, attaching the corresponding sanitary
authorization for each facility.
ii. Legalized license if applicable.
15
16. iii. Quality control agreement entered into with a pharmaceutical
laboratory authorized by the Institute and executed before a notary
public, if applicable.
ARTICLE 30 - In the case of imported finished, semi-finished, semi-manufactured or bulk
pharmaceutical products, the applicant shall be allowed to prove the manufacturer's compliance
with Good Manufacturing Practices in accordance with the provisions of articles 192 and 193, in
which case the requirements set forth in a.iv above shall not apply.
B. Technical information requirements
ARTICLE 31- A sanitary registration application shall be required to meet the following general
requirements in relation to the technical information of the pharmaceutical product, including the
following:
1. Clinical and pharmacological monograph in Spanish signed by the chief technical
officer or technical adviser.
2. Graphic labelling draft in Spanish intended for retail, clinical sales and medical
samples.
3. Draft of the healthcare professional information leaflet endorsed by relevant scientific
data and including the results of bioavailability and therapeutic equivalence studies in
the case of pharmaceutical products comprising active ingredients that are subject to
this requirement.
4. Draft of the patient information leaflet endorsed by relevant scientific data.
C. Pharmaceutical quality requirements
ARTICLE 32- A sanitary registration application shall be required to meet the following general
requirements to certify the pharmaceutical quality of the product, including the following
information:
1. Qualitative and quantitative composition of the pharmaceutical product in the
following order:
a) Quali-quantitative statement for each active ingredient.
b) Quali-quantitative statement for each excipient.
c) Qualitative statement of any excipient used and removed during the
manufacturing process, if applicable.
d) Quali-quantitative composition expressed in metric system units of mass or
volume, or units of biological activity. Whenever possible, the biological
activity shall be required to be indicated per unit of mass or volume.
e) Active ingredients and excipients shall be required to be designated by their
international non-proprietary names (INN) or otherwise by the existing
pharmacopoeial names. In the case of non-pharmacopoeial substances, the
16
17. chemical name in Spanish shall be used. No abbreviations or marks may be
used for designating active ingredients.
f) Any colourings in the product shall be required to be designated by their
generic names or otherwise by their chemical name or equivalents having
authorized colouring indexes in accordance with the relevant national
technical standard as approved by order of the Ministry; the same provision
shall apply when using coloured capsules.
2. With respect to the active ingredients used in the manufacture of pharmaceutical
products, the following information shall be required to be supplied:
a) Specifications and quality control methods, conforming to the requirements
listed in official texts or pharmacopoeias currently in force in Chile, or in
pharmacopoeial monographs if not indicated in the official texts.
b) Supplier and manufacturer of the active ingredients, including an analysis
report detailing all the characterizing parameters of the active ingredient.
c) Origin of the primary reference standard, including the corresponding
certificate of analysis indicating at least its origin, potency, traceability and
other relevant characterizing tests.
d) Spectrogram or chromatogram of the active ingredient and the standard
obtained by any instrumental method, if applicable.
e) Storage conditions of the active ingredient used as raw material.
3. Specifications and control methods for every excipient, conforming to the
requirements listed in official texts or pharmacopoeias currently in force in Chile, or in
pharmacopoeial monographs if not indicated in the official texts.
4. Analytical methodology in Spanish signed by the professional filing the application and
by the quality control manager of the pharmaceutical laboratory or the contracted
supplier.
a) The analytical methodology shall characterize the pharmaceutical product and
include controls as necessary to guarantee its quality, depending on the
manufactured pharmaceutical form.
b) The analytical methodology of all pharmaceutical products shall be required to
include the following general test methods: sensory description (appearance,
size, shape, colour, odour, etc.); selective identification of active ingredients;
titration, performance or activity of active ingredients; identification of
impurities if applicable; and description of the type and material of both
primary and secondary ary packaging.
c) Specific test methods according to the pharmaceutical form shall be
established pursuant to current additional technical standards issued by the
Institute.
d) The methodology is required to be validated, if not described in officially
recognized pharmacopoeias.
5. Special tests:
17
18. a) Modified-release pharmaceutical forms, such as delayed-release or enteric
prolonged-release forms and others, shall be required to be indicated as such
and endorsed by pharmacokinetic, dissolution or dissemination tests, or other
studies.
b) Therapeutic equivalence and bioavailability studies, in the case of
pharmaceutical products comprising active ingredients subject to this
requirement.
6. Fact sheet including analytical parameters and acceptance criteria characterizing the
product which, upon being made official, shall become the specifications that the
finished product shall be required to meet throughout its effectiveness period.
7. Proposed effectiveness period and storage and packaging conditions for both the
pharmaceutical drug and the reconstituted product if applicable, endorsed by the
corresponding stability tests, including the following:
a) Stability information, including at least: identification of the manufacturer and
the entity or individual responsible for conducting the stability test;
temperature and humidity conditions, packaging material and batches
(minimum 3 batches); test design and analytical procedures; and
specifications of the finished product; all of the above in accordance with the
Guide to the Stability of Pharmaceutical Products, a technical standard
approved by the Ministry at the proposal of the Institute.
b) When the product requires dilution prior to administration, the stability tests
for the formulation, the solvent (if included in the presentation) and
reconstituted product. In the event of the product requiring dilution and the
solvent not being included in the presentation, there shall be an indication as
to the recommended solvents; stability tests for the formulation and the
reconstituted product shall be additionally required.
c) If the product is required to be diluted for immediate administration, only a
compatibility study for the corresponding diluents shall be required.
d) In the case of an active ingredient that is not part of the authorized formula of
a registered pharmaceutical drug, the results of forced degradation studies
under stress conditions, as well as the requirements established in #2 above.
8. Technical information relating to the manufacturing process and the code for the
product, quality control, and physical-chemical data, presented in a record sheet
including flow charts and controls along the process.
ARTICLE 33 - For the purposes of determining the identity, potency, purity, stability, and other
physical, chemical, microbiological and bio-pharmaceutical requirements for drugs for which a
registration is sought, the Institute shall be required to observe the relevant rules in the following
pharmacopoeias and their supplements:
a) Chilean Pharmacopoeia.
b) International Pharmacopoeia.
c) European Pharmacopoeia.
18
19. d) United States Pharmacopoeia and the National Formulary.
e) British Pharmacopoeia.
f) French Pharmacopoeia.
g) German Pharmacopoeia.
h) German Homeopathic Pharmacopoeia.
i) Wilmar Schwabe Pharmacopoeia.
j) US Homeopathic Pharmacopoeia.
k) Mexican Homeopathic Pharmacopoeia.
l) Japanese Pharmacopoeia.
m) Spanish Pharmacopoeia.
n) Mexican Pharmacopoeia.
In addition, the technical reports of the World Health Organization Expert Committee on
biological, biotechnological, chemical, radioactive, and similar standards, and the provisions of title
21 of the United States “Code of Federal Regulations” (CFR), section 1.1, shall also be of relevance
for the purposes mentioned above. In the case of a pharmaceutical product that is not listed in any
of the foregoing official documents, the Institute may, with good reasons, accept or reject, either
totally or in part, the technical information supplied by the interested party.
ARTICLE 34- Should reference be made to tolerance margins or other specifications in the texts
mentioned in the preceding article, these shall be indicated in the application for registration so
that the Institute can decide about their adequacy.
ARTICLE 35- Due to the nature, diversity and extent of the general requirements set for the
pharmaceutical quality of products, they may be listed in additional technical standards approved
by the Ministry at the proposal of the Institute.
D. Safety and Efficacy requirements
ARTICLE 36- A sanitary registration application shall be required to include information on the
safety and efficacy of the product, including the following:
1. Studies on the development of the pharmaceutical product, including chemical,
pharmaceutical, and biological tests as appropriate for the proposed formulation and
their rationale.
2. Preclinical trials such as those conducted in vitro and/or with experimental animals
usually designed to gather further information as to whether more extensive studies
should be carried out in humans without exposing them to undue risk.
3. Selective pharmacological studies in animals.
4. Toxicological studies in animals, including acute and chronic toxicity, teratogenicity,
embryotoxicity, fertility, mutagenesis, and carcinogenesis tests, as well as any other
assays necessary for a proper evaluation of the safety and tolerance of a
pharmaceutical product pharmacist.
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20. 5. Phase I, II, and III clinical trials endorsing the safety and efficacy of a product for which
registration is sought. Trials of products that do not correspond to the formula
intended for registration may be submitted, provided that their pharmaceutical and
therapeutic equivalence has been established by the corresponding studies.
6. Pharmacokinetic tests, if applicable.
7. Studies to prove the bioavailability or therapeutic equivalence of a pharmaceutical
product whose registration is sought, in the event of products comprising active
ingredients that are subject to this requirement.
8. A chemical, pharmaceutical, and biological report, including analytical, chemical,
physical, chemical, biological or microbiological tests to determine if the product
intended for registration is in conformity with the stated composition and has the
appropriate quality, and whether the proposed control methods are in accordance
with the state of scientific knowledge, the formulation and pharmaceutical form are
suitable for their intended purposes, and the container is suitable for proper
preservation.
9. A toxicological and pharmacologic report, including preclinical trials reporting the
toxicity of the product and its proven pharmacological properties.
10. A clinical report prepared by independent experts evaluating the tests submitted by
the applicant with regard to the product having an adequate tolerance, the
recommended dosage being correct, and any eventual contraindications or side
effects.
2. Registration details and conditions for certain pharmaceutical drugs
ARTICLE 37 - The following conditions shall be required to be met for the registration of
pharmaceutical products comprising a combination of fixed-dose active ingredients:
a) Each active ingredient is required to contribute to the therapeutic effect of the
product, and the combination should contribute to improving patient compliance with
the treatment.
b) The dose of each component, the frequency of administration, and duration of the
treatment shall be required to render the combination safe and effective while
avoiding the danger of adverse reactions.
c) The ingredients including excipients used in the combination are required to be
chemically, pharmacologically, pharmacokinetically, and biopharmaceutically
compatible, either in vitro or in vivo, as appropriate.
d) Toxic or side effects should be the same or less than those found in each of the active
ingredients separately.
ARTICLE 38- Notwithstanding the foregoing, applications for the registration of pharmaceutical
products comprising a combination of fixed-dose active ingredients shall be rejected under the
following circumstances:
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21. a) The products have been indicated for treating diseases or symptoms having a different
natural course than the one mentioned in the registration for each of its active
ingredients unless proven otherwise.
b) Clinical, pharmacological or other tests subject to evaluation are not available for any
of the components.
ARTICLE 39 - In the case of combined pharmaceutical products, the applicant requesting their
registration shall be required to provide evidence of their safety and efficacy when used in the
combination. In addition, the applicant shall be required to provide further evidence as to the
following:
a) Each pharmaceutical drug should contribute to the therapeutic effect of the combined
product.
b) The dose for each drug as well as the frequency of administration and duration of the
treatment shall be required to render the combination safe and efficient without any
danger of causing adverse reactions.
c) The ingredients used in each pharmaceutical drug, including excipients, shall be
required to be chemically, pharmacologically, pharmacokinetically, and
biopharmaceutically compatible, both in vitro and in vivo as appropriate.
d) Toxic or side effects should be the same or less than those found in each of the active
ingredients separately.
Combined products may not include phytopharmaceutical or homeopathic products in association
with each other or with other pharmaceutical drugs.
ARTICLE 40 - Given the nature of phytopharmaceutical products, the following considerations shall
be taken into account for their registration:
a) Proof of their safety shall be required by submitting pre-clinical trials and toxicological
and phase I clinical studies, while their effectiveness shall be endorsed by phase II and
III clinical trials. In the event that upon requesting the sanitary registration of a
product there exists information in the official literature of different international or
foreign agencies such as the WHO, FDA or EMEA, such information shall be accepted
as valid in lieu of the above.
b) Applications shall be required to observe the provisions set forth under the general
registration requirements, including the following special rules:
i. Therapeutic equivalence studies shall not be required at the time of
registration or when requesting any subsequent modifications.
ii. The description of the manufacturing process shall be required.
iii. The generic name shall correspond to the taxonomic botanic denomination of
the plant providing the active ingredients.
iv. The quali-quantitative formula shall be required to include the type of plant
preparation used for the product, such as dry or fluid extracts, soft extracts,
powder or others, followed by the plant or parts thereof that have been
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22. employed in the preparation, plus their scientific name, concentration and its
equivalent plant marker, if applicable.
v. No narcotic or psychotropic substances or allopathic medicines shall be
allowed in the preparation.
vi. The identity and purity of the ingredients shall be determined in accordance
with foreign or international pharmacopoeias or sources of information, and
shall be required for validating the proposed analytical methodology.
vii. The analytical methodology for evaluating the finished product and the raw
materials should appear in any of the pharmacopoeias officially accepted in
Chile or in foreign sources of scientific information, or otherwise the
corresponding validation of the proposed analytical methodology shall be
required.
viii. Finished product specifications shall be required in accordance with the
pharmaceutical form of the product. Notwithstanding the foregoing, the
titration of active ingredients in the finished product may be replaced with the
titration of specific plant marker.
ix. Products comprising isolated or synthetic active ingredients shall not be
deemed to be phytopharmaceuticals, even if prepared from plant raw
materials.
ARTICLE 41 - Given the nature of homeopathic products, the following considerations shall be
taken into account for their registration:
a) Regarding information on the pharmaceutical quality of the product:
i. Generic names of active ingredients shall be required to be in Latin as set
forth in recognized pharmacopoeias.
ii. In qualitative-quantitative formulas, each homeopathic substance shall be
required to be in Latin, followed by the final dilution (i.e. in the finished
product) and concentration.
iii. A clear and complete description of the starting raw materials used in the
preparation of the homeopathic substance shall be required, in addition to
their characterization, method of preparation, and any physicochemical
controls to which they have been submitted.
iv. A description of the manufacturing methods used for preparing the finished
product.
v. Homeopathic pharmaceutical products shall be required to meet finished
product specifications according to the pharmaceutical form in which they are
presented, like any other drugs, except for the titration of the active
ingredients in the finished product.
vi. When homeopathic products are administered as conventional tablets,
disintegration tests shall be required instead of dissolution tests.
b) With respect to information endorsing the efficacy and safety of the product, in
addition to the texts particularly mentioned in article 33 herein, the use of other
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23. pharmacopoeias, documents issued by WHO expert committees, or other references
acknowledged by decree of the Ministry may be authorized under the formula “By
order of the President of the Republic” at the proposal of the Institute.
ARTICLE 42 -In addition to meeting general product registration requirements, applications for the
sanitary registration of biological products shall be required to include the following information:
a) Name of the product, in the following order:
i. Trade name or otherwise the generic (INN) or pharmacopoeial name. Vaccines
shall be designated with a Latin name after the disease against for which they
provide protection.
ii. The manufacturing process when the active ingredients are living or dead
microorganisms, referring to the process as “living”, “attenuated,”
conjugated”, “inactivated” or others.
iii. The manufacturing method, in the case of active ingredients produced by a
living organism that has been genetically modified, referring to the process as
“recombinant”.
iv. Pharmaceutical form and dosage, if appropriate.
b) Quali-quantitative composition in the following order:
i. Quali-quantitative statement for each active ingredient.
ii. Quali-quantitative statement for each of excipient.
iii. Quali-quantitative statement for any adjuvant or adsorbing agent in the
product, if applicable.
iv. Quali-quantitative composition shall be required to be stated (if applicable) in
units of mass or volume in the metric system. The protein content or units of
biological activity shall be required to be stated in units of mass or volume, or
alternatively in International Units.
v. In the case of products for active immunization, the quali-quantitative
composition shall be preferably stated in unit doses.
vi. Active ingredients and excipients shall be required to be designated by their
international non-proprietary names (INN) or otherwise by existing
pharmacopoeial names. Substances other than drugs shall be required to be
named after their chemical or biological denomination, while vaccines shall
bear a Latin name in accordance with disease against which they offer
protection. No abbreviations or marks may be used for designation.
vii. The taxonomic designation of microorganisms shall be required to be stated in
short, including the strain, serotype or other subspecies information when
appropriate.
viii. The nature of any cellular system used for manufacturing biological products
shall be required to be disclosed, as well as the use of recombinant DNA or
RNA technology.
ix. In the event of an active ingredient being a living microorganism, the chemical
compound used in the chemical inactivation method shall also be disclosed.
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24. x. Should the quali-quantitative statement include adsorbing agents such as
aluminium, the quantitative statement shall be required to be in terms of
amount per dose.
xi. Preservatives shall be quantitatively detailed at the end of the formula, if
present, which shall also be required to include qualitative details of antibiotic
residues and antimicrobial agents used in the manufacturing process that may
potentially trigger allergic reactions in certain individuals.
xii. Any colourings in the product shall be required to be designated by their
generic names or otherwise by their chemical name or equivalents having
authorized colouring indexes in accordance with the relevant national
technical standard as approved by a decree of the Ministry. The same
provision shall apply to the use of coloured capsules.
c) Active ingredient requirements, including quality and purity specifications and control
methods therefor, along with following information:
i. Manufacturer and supplier of the active ingredient.
ii. Supplier and traceability (if applicable) of the reference standard used for
describing the active ingredient.
iii. Storage conditions of the active ingredient, including temperature, humidity
and quality of the package.
iv. Description of other desired elements and related compounds, including their
properties and characteristics, structure, biological activity or others.
v. When describing active ingredients obtained from human blood or blood
products, the information shall be required to further indicate the procedures
followed to guarantee to the fullest extent the absence of potentially
pathogenic agents that may be transmitted, including:
1. Donor selection protocols.
2. Plasma fractionation method.
3. Testing of the plasma before and during the process, including the
determination of hepatitis B virus (HBV) surface antigens and
antibodies to Human Immunodeficiency Virus (HIV) and Hepatitis C
virus (HCV ), as well as others as appropriate.
4. Storage temperature of the active ingredient and monitoring method.
5. Validity and expiry date.
6. Methods of inactivating infectious contaminants that the starting
material may contain, as well as intermediate and final products.
d) Manufacturing method:
i. Description of the manufacturing method, including process controls and
tolerance.
ii. Description of the manufacturing process, including raw materials, critical
steps and reprocessing if applicable, as well as an indication as to how routine
monitoring methods have been selected for controlling the finished product.
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25. iii. Description of source and starting materials for the production of the
biological active ingredient.
iv. Description of actions taken to prevent or control contamination by both viral
and non-viral adventitious agents such as HIV, HSV, HCV, transmissible
spongiform encephalopathy (TSE), bacteria, mycoplasma or fungi.
v. Description and information about the validation process.
e) Control of excipients:
i. Quality and purity specifications, as well as methods of controlling excipients
used in the formulation pursuant to the requirements set forth in official
documents authorized hereunder or otherwise in their monographs.
ii. A certification attesting to the absence of raw materials from animal species
affected by TSE and other transmissible diseases.
f) Control of finished products:
i. At least the following information shall be required:
Description and appearance (shape, colour, odour and clarity if
applicable).
Selective identification of active ingredients.
Titration, potency or activity of active ingredients.
Determination of impurities, if applicable.
Description of the nature and type of both primary and secondary
packaging material and accessories, in the event of the latter being in
contact with the pharmaceutical product.
Any other information as required by the Institute according to the
nature and composition of the biological product.
ii. Indication of acceptance criteria and minimum and maximum values if
considered to be deciding factors.
iii. Fact sheet, including laboratory parameters and acceptance criteria
characterizing the biological product which, upon being made official, shall
become the specifications that the finished product shall be required to meet
throughout its effectiveness period.
g) Packaging material:
i. Description of the nature and type of both primary and secondary packaging
material and accessories, in the event of the latter being in contact with the
pharmaceutical product.
ii. Information regarding the choice of primary packaging materials in view of the
protection against light and moisture, and their compatibility with the
pharmaceutical form and its administration.
iii. When the dosage form is sterile, information shall be required on the integrity
of the package sealing system used to prevent microbial contamination.
h) Stability tests for the formulation, the solvent and the reconstituted product, as
appropriate:
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26. i. The information on the stability of the product shall be required to include at
least the following:
Formula under study.
Identification of the manufacturer and the entity or individual
responsible for conducting the stability test.
Temperature and humidity conditions, packaging material and
batches (minimum 3 batches), test design and analytical procedures,
and specifications of the finished product, all of the above in
accordance with the Guide to the Stability of Pharmaceutical Products
referred to in article 32.
ii. In the event of a biological product containing a new active ingredient in the
field of medicine in Chile, the information shall be required to include the
results of studies on forced degradation stability and stress conditions.
iii. Proposed effectiveness period and storage precautions as endorsed by the
corresponding stability test, in addition to the effectiveness period for the
reconstituted product, if applicable.
iv. In the event of the product requiring dilution prior to administration, the
information shall be required to include compatibility and stability tests with
adequate diluents, as appropriate.
i) Efficacy and safety requirements.
In the case of biotechnological products, a technical standard shall be approved by order of the
Ministry at the proposal of the Institute to determine active ingredients and their presentation, for
which abridged clinical studies endorsing the efficacy and safety of the product shall be accepted
based on the existence of another registered biotechnological product comprising the same active
ingredients, unit dose, pharmaceutical product and route of administration.
Notwithstanding the foregoing, the applicant shall be required to submit comparative studies
including the reference product for each indicated active ingredient in order to properly
characterize the product and provide evidence as to the similarity in their nature.
SECTION THREE
REGISTRATION APPLICATION PROCEDURES
ARTICLE 43 - The sanitary registration application and any required information depending on the
type of pharmaceutical product shall be submitted to the Institute of Public Health using the
approved forms upon payment of the corresponding fee.
A register of the application shall be kept on a written or electronic file comprising documents
submitted by interested parties, stating the time and date of presentation and having a reference
number for reference and tracking purposes, upon payment of the fee corresponding to the first
admissibility phase of the application.
ARTICLE 44 - Within ten working days, the Institute shall be required to review the application
form and the information supplied, and deliver a statement on its admissibility.
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27. ARTICLE 45 - Upon acceptance of the application for further evaluation, the interested party shall
be given notice of this decision in order to proceed with the payment of fees corresponding to the
next phase of the procedure.
An application may only be rejected in the absence of compliance with the requirements
hereunder and any supplementary regulations, according to the type of pharmaceutical drug, and
the Institute shall be required to indicate any missing information required to overcome the
objection, which shall be submitted within five working days, upon which the Institute shall
proceed as provided in the preceding paragraph or eventually turn down the application.
ARTICLE 46 - Upon admission of the registration procedure, the application shall be forwarded to
the appropriate department for the separate analysis of technical and administrative information.
The administrative records referred to in article 29.10 shall be first checked by the legal
consultancy department.
Technical records concerning requirements in relation to the technical information,
pharmaceutical quality, safety and efficacy of the product, as well as any other particular records
as required by the type of product pursuant to the provisions of the preceding paragraph, shall be
separated and forwarded to specialized technical offices for assessment in accordance with these
presents.
ARTICLE 47 - Should the aforementioned assessment result in a favourable outcome and within six
months from the date of payment of the corresponding fee, the requested registration shall be
granted by enactment of a resolution notified to the formal applicant.
ARTICLE 48 - The sanitary registration of a pharmaceutical drug shall be required to contain at
least the following information:
a) Name and address of the holder.
b) Name and address of the manufacturer, importer, manufacturing or packaging
pharmaceutical laboratory, quality control laboratory, distributor, and licensor, if
applicable.
c) Registration number.
d) Name of the pharmaceutical product.
e) Full qualitative and quantitative composition.
f) Pharmaceutical form.
g) Therapeutic group.
h) Storage conditions and effectiveness period.
i) Packaging and presentations.
j) Authorized therapeutic indications.
k) Prescribing and retail conditions pursuant to Ministry regulations.
l) Whether the product is subject to legal control, batch control or others, indicating the
conditions for the same.
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28. m) Authorization restrictions concerning the validity of the registered product and the
need to supervise the use thereof.
n) Specific obligations of the holder.
o) The obligation to inform about the first batch of production or import for distribution
in any shape or form pursuant to the provisions of article 71 herein.
p) Other relevant information depending on the nature and specific composition of each
pharmaceutical product and relating to the production, import, quality control,
storage, distribution or delivery of the product, and the protection of undisclosed
data.
q) The authorized graphic label, the patient information leaflet or insert, the healthcare
professional information leaflet, and the specifications and testing methodology of the
finished product must be included in one or several stamped attachments, which shall
be deemed to be an integral part of the registration certificate.
ARTICLE 49 - A sanitary registration may be rejected under the following circumstances:
Incidental issues: upon notification, the applicant shall have 15 working days to make
any submissions as deemed appropriate, after which the Institute shall be required to
issue a final resolution.
Inadequate tests or insufficient information: upon notification, the applicant shall
have 30 working days to provide further information, and the sanitary registration
shall be granted if such information is sufficient to fulfil the conditions listed above.
In the event that such additional information is not submitted within the allowed period of time,
or if despite having been submitted in time such information is once again deemed to be
insufficient, the Institute shall request the Ministry of Health to rule on the rejection of the
registration.
The Ministry shall be required to issue a report on the rejection of the registration within 10
working days and forward it to the Institute so that it passes a substantiated resolution which shall
be notified to the applicant.
ARTICLE 50 - Pursuant to the provisions of law no. 19,880, during the prosecution of a sanitary
registration the interested party may make submissions and furnish documents or other evidence
which shall be considered for the grant or rejection of the relevant sanitary registration.
Upon grant of the sanitary registration, the corresponding resolution shall become available on
the official website of the Institute of Public Health.
In the event that such information cannot be disclosed pursuant to the provisions of law no.
19,039, the provisions under said law and other supplementary regulations shall be observed.
SECTION 4
SPECIAL REGISTRATION PROCEDURES
1. Short registration procedure
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29. Article 51 - The regular registration procedure may be simplified to reduce processing times by
order of the Ministry of Health under any of the following circumstances:
1. The pharmaceutical product is required to be supplied to the public in compliance
with health plans or programmes approved by the Ministry to address health risk
situations or particular conditions specific for certain groups of people in the context
of national public health interests.
2. The pharmaceutical product has been included in a list of products under the National
Formulary, in which case the applicant shall be required to use the formulary
monographs to speed up the prosecution of the registration. The Institute shall be
required to reduce registration processing times depending on the stage of the
prosecution. In any case, the entire prosecution may not exceed four months.
2. Simplified registration procedure
ARTICLE 52 - The regular registration procedure may be simplified upon the interested party's
request by leaving out certain information as indicated below:
1. In the case of pharmaceutical products comprising the same active ingredient, in the
same amounts, pharmaceutical form and route of administration as another
registered product whose registration has not been cancelled by the Institute due to
public health reasons, information on safety and efficacy shall not be required to be
submitted, unless the Institute by means of a substantiated decision determines the
need for some or all of such information. In the case of a non-standard release
pharmaceutical product, the corresponding therapeutic equivalence studies shall be
required to be submitted.
2. In the case of widely recognized active ingredients which have been the subject of
ample experimentation so that their efficacy, safety of use and adverse reactions are
widely reviewed in the scientific literature, information on pre-clinical trials may be
replaced with the relevant bibliography. In addition, scientific information relating to
the efficacy and safety of the product intended for registration may also be partially
omitted, in which case the Institute shall review the application and reasonably
require all the necessary information.
3. In the event of a pharmaceutical product being pharmaceutically equivalent to a
registered product and listed under active ingredients for which evidence of
therapeutic equivalence has been required, the corresponding studies shall be
required to be submitted pursuant to specific regulations.
4. In the event of a product having been manufactured in Chile for the sole purpose of
exportation, deemed to be a pharmaceutical product under Chilean regulations and a
food product in the country of destination as certified by the relevant health
authorities, information on safety and efficacy may be omitted unless the Institute by
means of a substantiated decision determines the need for some or all of such
information.
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30. ARTICLE 53 - The simplified sanitary registration procedure shall not be applicable in the following
cases:
a) The pharmaceutical product for which registration is sought appears for the first time
in the field of medicine in Chile, except under the provisions of article 52.2.
b) The pharmaceutical product for which registration is sought comprises the same
active ingredient as another registered product, and the disclosure of information
about such product is protected under the provisions of section 2, title VIII of law no.
19,939.
c) The pharmaceutical product for which registration is sought is concerned with a new
therapeutic use, dosage schedule, extension of a previously approved route of
administration, or age group.
d) The drug product for which registration is sought health presents a change in the
composition and concentration of active ingredients over a registered formula, or
contains new salts, esters, complexes or isoforms of the active ingredients in a
registered pharmaceutical product, or comprises combinations of separately
registered or unregistered fixed-dose active ingredients.
e) In the event of the pharmaceutical product for which registration is sought being in a
different pharmaceutical form and wherein the release of active ingredients has been
modified.
f) In the case of a combined pharmaceutical product for which registration is sought for
the first time.
g) When requesting the registration of a biological product.
ARTICLE 54 - The registration procedure of homoeopathic pharmaceutical products may only be
simplified upon meeting all of the following conditions:
a) The route of administration is oral or external.
b) Absence of specific therapeutic indications in the graphic label or in healthcare
professional and patient information leaflets.
c) The product comprises a single homoeopathic substance to a degree of dilution that
guarantees the safety of the drug.
d) The homoeopathic substance making up the pharmaceutical product is obtained from
a plant, animal, mineral or chemical substances and raw materials described in
officially recognized pharmacopoeias in accordance with homoeopathic
manufacturing procedures also described in such texts.
SECTION 5
TERM, SUSPENSION AND CANCELLATION OF THE SANITARY REGISTRATION
ARTICLE 55 - The sanitary registration of a pharmaceutical product shall be valid for a term of five
years from the date of grant and may be renewed for equal and successive periods provided that
no cancellation is in effect and under the following conditions:
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31. 1. Payment of corresponding fees.
2. The objections for suspending the sanitary registration have been overcome within
the required term. In the event of the sanitary registration expiring before such term,
the renewal shall be requested within 15 days after expiration of the term allowed to
overcome the objections.
3. Absence of outstanding fines or compliance with other sanitary measures or penalties
imposed by the Institute, if applicable, in connection with the registration for which
renewal is sought.
The renewal of the sanitary registration shall be rejected upon the holder failing to fulfil some of
the obligations under such registration.
ARTICLE 56 - The application for renewing a sanitary registration shall be submitted to the
Institute, and in the case of imported products, it shall be required to be accompanied by the
pharmaceutical product certificate, registration certificate, sanitary authorization or official
certifications recommended by the World Health Organization, issued by the relevant authorities
in the country of origin, certifying that the manufacturing or storing facilities comply with health
regulations in their respective country, that the product is registered in said country pursuant to
current legislation, indicating the authorized formula in full, and that the sale of the product is
subject to a restrictive regime or other special sanitary controls, if applicable.
ARTICLE 57 - The renewal of the registration shall be required to bear the same number assigned
upon registration, as well as the year of renewal and the expiry date.
ARTICLE 58 - Sanitary registrations could be suspended for any of the following reasons:
1. If significant changes are noticed in connection with the therapeutic indication,
composition, dosage forms, application or other conditions as indicated on the label or
the healthcare professional information leaflet or advertised, and such changes do not
conform to the approved sanitary registration.
2. If the quality of the product is not up to standard in two batches.
The resolution whereby the sanitary registration is suspended shall be required to indicate the
scope of the suspension and set a deadline for overcoming the objections causing the suspension;
upon failure to overcome said objections, the registration shall be cancelled.
ARTICLE 59 - Sanitary registrations may be cancelled ex officio or upon complaint of any interested
parties by order of the Ministry of Health for any of the following reasons:
a) When on the basis of scientific information from the World Health Organization or
foreign or international bodies or organizations, or arising from its own research, the
Institute has the conviction that a product is not safe or effective as indicated in the
relevant sanitary registration, and one of the following situations develops:
i. Manifest danger to public health.
ii. Unfavourable therapeutic risk - benefit ratio.
iii. Therapeutic inefficacy.
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32. b) Upon finding that any piece of information provided in the sanitary registration has
been proved to be false.
c) Upon failure to overcome the objections for suspension within the term fixed for such
purpose.
ARTICLE 60 - The holder of the cancelled or suspended sanitary registration shall be responsible
for taking the necessary measures to collect, destroy or denaturate, as required by the Institute,
all pharmaceutical units in storage on the premises or distributed according to current regulations
to other pharmaceutical and healthcare facilities, and for informing users who could potentially
use the concerned product.
ARTICLE 61 - The suspension and cancellation of a sanitary registration shall be determined by the
Institute by means of a substantiated decision notified to the holder.
ARTICLE 62 - Notwithstanding the provisions of article 59, the Institute may cancel a sanitary
registration after conducting relevant preliminary investigations, in addition to penalties imposed
pursuant to the provisions of article 174 of the Sanitary Code.
SECTION 6
SANITARY REGISTRATION AMENDMENTS
1. Technical and sanitary aspects
ARTICLE 63 - Amendments to the sanitary registration of a pharmaceutical drug may be produced
upon a resolution of the Institute, ex officio, or at the request of the holder.
ARTICLE 64 - The Institute may request, by means of a substantiated decision, to introduce
amendments to the registration within a certain period of time to guarantee the quality, safety
and efficacy in the use of one or more pharmaceutical drugs when on the basis of scientific
information from the World Health Organization or foreign or international bodies or
organizations, or arising from its own research, the Institute has the conviction that some of the
authorized use conditions poses a risk to their safety and efficacy.
ARTICLE 65 - Upon the holder's request and by means of a resolution, the Institute may accept
analytical, technical, and legal amendments including the following:
1. Expression of the formula, including the composition of excipients.
2. Specifications of the finished product, methods of control, and effectiveness period.
3. Presentation, content, type of container and additional items or devices for
administration. In the event of the primary container having been modified, the
corresponding stability tests shall be additionally required, if applicable.
4. Retail conditions.
5. Name and graphic label.
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