This document from Medsafe provides guidance on how to categorize products in New Zealand based on their ingredients, purpose of use, and presentation. It outlines that products are categorized as dietary supplements, foods, cosmetics, or medicines/medical devices. Medicines achieve their purpose through pharmacological means while medical devices do not. It includes a table showing example products and their categories, and information on how to request a product categorization from Medsafe.
This document provides information about the US Food and Drug Administration (FDA). It describes the organization and responsibilities of the FDA, including protecting public health by regulating food, drugs, medical devices, and other products. It also summarizes key FDA centers like the Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research. The document introduces the Pharmaceutical Inspection Convention, its objectives to harmonize good manufacturing practices among countries.
This document provides an overview of global regulatory requirements for nutraceuticals. It begins by defining nutraceuticals and discussing their classifications. It then examines regulations for nutraceuticals in various countries and regions including the US, India, Canada, Japan, Europe, Australia, China, and Latin America. Key regulatory bodies and their definitions and approaches are outlined for each location. The conclusion notes the challenges of varying global regulations and need for standardization to improve efficacy and health benefits of nutraceuticals.
The FDA is the government agency responsible for regulating food, drugs, medical devices, and other products in the United States. It has headquarters in Maryland and over 200 field offices across the country. The FDA regulates items like foods, drugs, medical devices, vaccines, and more to ensure they are safe and properly labeled. It is made up of centers that focus on specific product areas like drugs, devices, food, tobacco, and more. The document provides details on the FDA's structure, responsibilities, processes, and international collaboration efforts.
The document discusses the organization of the US Food and Drug Administration (FDA). It describes that the FDA regulates food, drugs, medical devices, cosmetics, and tobacco. It is organized into six product centers that regulate specific areas, a research center, and two offices. The centers regulate drugs, biologics, devices, food, veterinary medicine, and tobacco. The Office of Regulatory Affairs conducts inspections and investigations. The Office of the Commissioner provides leadership. Employment in 2013 totaled 14,589 across the various centers and offices.
Introduction to pharmaceutical regulatory agenciesDoaa Abouzeid
Regulatory authorities act as a guardian that ensures the safety, efficacy and quality of drugs available to the public.
They work to identify the strengths and weaknesses of drug regulation and to propose strategies to improve drug regulation.
The international regulatory organizations whether they are Governmental or Non-governmental play an essential role in all aspects of pharmaceutical regulations related to drug product registration, manufacturing, distribution, price control, marketing, research and development, and intellectual property protection.
The Therapeutic Goods Administration is the regulatory body for therapeutic goods in Australia.he TGA is responsible for conducting assessment and monitoring activities to ensure that therapeutic goods available in Australia are of an acceptable standard and that access to therapeutic advances is in a timely manner.
The document provides information about various regulatory authorities that regulate medicines and medical devices. It discusses the US FDA, UK MCA, TGA of Australia, and their roles and responsibilities. The US FDA regulates food, drugs, medical devices, cosmetics, and other products in the US. The UK MCA was formed by merging the MCA and MDA and is responsible for ensuring medicines and devices are safe and work properly in the UK. The TGA regulates therapeutic goods including medicines and medical devices to ensure their quality, safety and performance in Australia.
The document provides an overview of drug regulation systems in India, the United States, and other countries. It discusses the key functions of drug regulatory agencies, which include product registration, regulating drug manufacturing and distribution, monitoring drug safety and efficacy, and regulating drug promotion and information. The main regulatory bodies in India are the Central Drugs Standard Control Organization and other organizations like the Indian Council of Medical Research. In the US, the main regulatory agency is the Food and Drug Administration, which aims to promote health by reviewing research and ensuring drugs are safe. The document also discusses regulatory agencies in other countries like Japan.
This document provides information about the US Food and Drug Administration (FDA). It describes the organization and responsibilities of the FDA, including protecting public health by regulating food, drugs, medical devices, and other products. It also summarizes key FDA centers like the Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research. The document introduces the Pharmaceutical Inspection Convention, its objectives to harmonize good manufacturing practices among countries.
This document provides an overview of global regulatory requirements for nutraceuticals. It begins by defining nutraceuticals and discussing their classifications. It then examines regulations for nutraceuticals in various countries and regions including the US, India, Canada, Japan, Europe, Australia, China, and Latin America. Key regulatory bodies and their definitions and approaches are outlined for each location. The conclusion notes the challenges of varying global regulations and need for standardization to improve efficacy and health benefits of nutraceuticals.
The FDA is the government agency responsible for regulating food, drugs, medical devices, and other products in the United States. It has headquarters in Maryland and over 200 field offices across the country. The FDA regulates items like foods, drugs, medical devices, vaccines, and more to ensure they are safe and properly labeled. It is made up of centers that focus on specific product areas like drugs, devices, food, tobacco, and more. The document provides details on the FDA's structure, responsibilities, processes, and international collaboration efforts.
The document discusses the organization of the US Food and Drug Administration (FDA). It describes that the FDA regulates food, drugs, medical devices, cosmetics, and tobacco. It is organized into six product centers that regulate specific areas, a research center, and two offices. The centers regulate drugs, biologics, devices, food, veterinary medicine, and tobacco. The Office of Regulatory Affairs conducts inspections and investigations. The Office of the Commissioner provides leadership. Employment in 2013 totaled 14,589 across the various centers and offices.
Introduction to pharmaceutical regulatory agenciesDoaa Abouzeid
Regulatory authorities act as a guardian that ensures the safety, efficacy and quality of drugs available to the public.
They work to identify the strengths and weaknesses of drug regulation and to propose strategies to improve drug regulation.
The international regulatory organizations whether they are Governmental or Non-governmental play an essential role in all aspects of pharmaceutical regulations related to drug product registration, manufacturing, distribution, price control, marketing, research and development, and intellectual property protection.
The Therapeutic Goods Administration is the regulatory body for therapeutic goods in Australia.he TGA is responsible for conducting assessment and monitoring activities to ensure that therapeutic goods available in Australia are of an acceptable standard and that access to therapeutic advances is in a timely manner.
The document provides information about various regulatory authorities that regulate medicines and medical devices. It discusses the US FDA, UK MCA, TGA of Australia, and their roles and responsibilities. The US FDA regulates food, drugs, medical devices, cosmetics, and other products in the US. The UK MCA was formed by merging the MCA and MDA and is responsible for ensuring medicines and devices are safe and work properly in the UK. The TGA regulates therapeutic goods including medicines and medical devices to ensure their quality, safety and performance in Australia.
The document provides an overview of drug regulation systems in India, the United States, and other countries. It discusses the key functions of drug regulatory agencies, which include product registration, regulating drug manufacturing and distribution, monitoring drug safety and efficacy, and regulating drug promotion and information. The main regulatory bodies in India are the Central Drugs Standard Control Organization and other organizations like the Indian Council of Medical Research. In the US, the main regulatory agency is the Food and Drug Administration, which aims to promote health by reviewing research and ensuring drugs are safe. The document also discusses regulatory agencies in other countries like Japan.
The document provides an overview of the U.S. Food and Drug Administration (FDA). It discusses the history, mission, organization and functions of the FDA. Key points covered include what products and areas the FDA regulates and does not regulate, FDA advisory committees, the Code of Federal Regulations (CFR), Orange Book, Investigational New Drug applications, New Drug Applications, and other FDA processes.
This document provides information on WHO GMP compliance for Boswellia Serrata extract product Wokvel. It discusses the active ingredients in Boswellia Serrata, the composition and dosage of Wokvel tablets, indications for use, and required documentation for WHO GMP certification including site master file, water and air quality manuals, validation protocols, and quality management systems. It also summarizes the roles of regulatory bodies like CDSCO and DCGI in India and minimum documentation checklists for herbal drug products.
The document discusses the European Medicines Agency (EMEA), which is responsible for evaluating and supervising medicines in the European Union. It describes the various committees within EMEA, including the Committee for Medicinal Products for Human Use (CHMP) which authorizes medicines, the Committee for Orphan Medicinal Products (COMP) which designates orphan drugs for rare diseases, and others focused on veterinary medicines, herbal medicines, and pharmaceutical regulation. The EMEA ensures that authorized medicines meet quality, safety, and efficacy standards and monitors medicines once they reach the market.
Herbal medicines are popular because of experience and the abundant
availability of plants in India due to its varied climatic zones. India has
around 45,000 species of plants, out of which 15,000–20,000 plants have
proven medicinal value.
This document provides guidance for applicants on the data requirements for submitting veterinary medicinal product applications to the Saudi Food and Drug Authority (SFDA). It outlines the key parts of a dossier, including:
- Part 1 which summarizes administrative information, the product characteristics, and critical summaries of quality, safety, efficacy, and residues (where applicable).
- Parts 2, 3 and 4 which specify the quality, safety, residues and preclinical/clinical data for pharmaceutical products, and the quality, safety and efficacy data for immunological products.
- Exceptions and additional requirements for generic and similar biological products are also described. The necessary studies will be determined on a case-by-case basis depending on the product
The passage summarizes the major changes to food and drug regulation in the Philippines from the passage of the Food and Drug Administration Act of 2009. Key points:
- The new law created the Food and Drug Administration (FDA) under the Department of Health, headed by a Director-General, to oversee food, drug, medical device, and cosmetic regulation.
- It consolidated regulatory powers over these products under the FDA, affecting two existing agencies. The new law aims to protect public health and establish an effective regulatory system.
- Major changes include new powers for the FDA, reorganization within the Department of Health, and establishment of new units within the FDA. The FDA has since drafted new rules and
The Ministry of Health, Labour and Welfare (MHLW) is Japan's governmental authority that issues regulations and guidelines for pharmaceuticals. The Pharmaceuticals and Medical Devices Agency (PMDA) works with MHLW as Japan's main regulatory body, located in Tokyo. PMDA is responsible for reviewing marketing applications, monitoring post-marketing safety of drugs and devices, and providing compensation for adverse reactions. The drug approval process in Japan involves IND applications reviewed by PMDA and IRB, as well as regulatory reviews and approvals conducted according to a common technical document format.
The document discusses two regulatory agencies - the Therapeutic Goods Administration (TGA) in Australia and the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK. The TGA regulates medicines, medical devices, and chemicals in Australia, ensuring they are safe and effective. It assesses products and places them on the Australian Register of Therapeutic Goods. The MHRA regulates medicines and medical devices in the UK, authorizing their sale and monitoring safety. It assesses products, oversees inspections of manufacturers, and monitors adverse events to safeguard public health. Both agencies aim to balance product access, innovation, and protecting public health.
The FDA regulates food, drugs, medical devices, cosmetics, and other products. It was established in 1930 as part of the US Department of Health and Human Services. The FDA's headquarters is in Maryland and it has many field offices across the US and internationally. Its goals are to ensure consumer safety, increase access to medical products, and improve product quality and manufacturing processes. It regulates a wide range of products from food to drugs to medical devices and ensures they are safe before reaching consumers.
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The document discusses regulations around biocidal products in the European Union. It provides definitions and explains that under the Biocidal Product Regulation, all biocidal products must be authorized before being placed on the market. Applications require approval of both the active substances within biocidal products and of the products themselves, a process that typically takes at least two years. The deadline for existing biocidal products to complete authorization is September 2015.
Definitions according to Drug Regulatory Authority of Pakistan (DRAP medical ...Arooj Abid
This document defines key terms related to medical devices and their regulation in Pakistan. It provides definitions for different types of medical devices including active devices, implants, and in vitro diagnostics. It also defines terms related to the regulation of medical devices such as clinical evaluation, clinical investigation, misbranded devices, notified bodies, and essential principles. The definitions cover a wide range of topics from different types of medical devices to regulatory concepts, organizations, and processes.
This document provides an overview of the US Food and Drug Administration (FDA) in 3 paragraphs. It discusses that the FDA was formed in 1906 and is responsible for regulating foods, drugs, medical devices, and other products. It describes the FDA's structure and responsibilities across its centers and offices. The document also provides brief summaries of the FDA approval processes for drugs, medical devices, and food products.
This document provides information on neutraceuticals and the regulatory framework for neutraceuticals in India. It defines neutraceuticals as food or food components that provide health or medical benefits. The key regulatory body is the Food Safety and Standards Authority of India (FSSAI), which establishes standards for neutraceutical products and licensing. The document outlines labeling requirements, restrictions, and documents needed to apply for a license to manufacture or sell neutraceuticals in India.
The Therapeutic Goods Administration (TGA) regulates therapeutic goods in Australia to protect public health and safety. It evaluates medicines and medical devices to ensure they are safe, effective and of high quality before being supplied in Australia. The TGA is part of the Australian Government Department of Health and has approximately 750 staff from various scientific, medical and administrative backgrounds. It undertakes pre-market evaluations, licenses manufacturers, monitors the market post-approval and maintains the Australian Register of Therapeutic Goods which lists all approved medicines and devices. Higher risk products undergo a rigorous approval process while lower risk goods follow a streamlined listing process.
Regulatory agencies are independent government organizations that create and enforce rules to protect public safety and welfare. Some of the key regulatory agencies described in the document are the Environmental Protection Agency (EPA) which protects the environment, the Federal Communications Commission (FCC) which regulates telecommunications, and the Food and Drug Administration (FDA) which ensures the safety of food and medicine. These agencies have the power to fine or shut down businesses that violate their regulations.
Regulations in India (ASU DTAB, ASU DCC), Regulation of
manufacture of ASU drugs - Schedule Z of Drugs & Cosmetics Act for ASU drugs.
Introduction
Regulatory Requirements
Key function of regulatory agencies
Regulation in India
DRUG TECHNICAL ADVISORY BOARD
Drugs Consultative committee-DCC
Schedule Z of Drugs & Cosmetics Act for ASU drugs.
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.
This document provides information on medical devices used in equine medicine. It defines a medical device as an instrument or article that is used to diagnose, cure, mitigate, treat or prevent disease, and which does not achieve its purpose through chemical action or metabolism. For human medicine, devices are classified from Class I to III based on risk. While the FDA regulates human medical devices, there is no approval process for veterinary devices, though they cannot be misbranded or mislabeled. Practitioners can use veterinary devices for their intended purposes but should be aware they have not been evaluated for safety or efficacy if used as pharmaceuticals.
The document provides an overview of the U.S. Food and Drug Administration (FDA). It discusses the history, mission, organization and functions of the FDA. Key points covered include what products and areas the FDA regulates and does not regulate, FDA advisory committees, the Code of Federal Regulations (CFR), Orange Book, Investigational New Drug applications, New Drug Applications, and other FDA processes.
This document provides information on WHO GMP compliance for Boswellia Serrata extract product Wokvel. It discusses the active ingredients in Boswellia Serrata, the composition and dosage of Wokvel tablets, indications for use, and required documentation for WHO GMP certification including site master file, water and air quality manuals, validation protocols, and quality management systems. It also summarizes the roles of regulatory bodies like CDSCO and DCGI in India and minimum documentation checklists for herbal drug products.
The document discusses the European Medicines Agency (EMEA), which is responsible for evaluating and supervising medicines in the European Union. It describes the various committees within EMEA, including the Committee for Medicinal Products for Human Use (CHMP) which authorizes medicines, the Committee for Orphan Medicinal Products (COMP) which designates orphan drugs for rare diseases, and others focused on veterinary medicines, herbal medicines, and pharmaceutical regulation. The EMEA ensures that authorized medicines meet quality, safety, and efficacy standards and monitors medicines once they reach the market.
Herbal medicines are popular because of experience and the abundant
availability of plants in India due to its varied climatic zones. India has
around 45,000 species of plants, out of which 15,000–20,000 plants have
proven medicinal value.
This document provides guidance for applicants on the data requirements for submitting veterinary medicinal product applications to the Saudi Food and Drug Authority (SFDA). It outlines the key parts of a dossier, including:
- Part 1 which summarizes administrative information, the product characteristics, and critical summaries of quality, safety, efficacy, and residues (where applicable).
- Parts 2, 3 and 4 which specify the quality, safety, residues and preclinical/clinical data for pharmaceutical products, and the quality, safety and efficacy data for immunological products.
- Exceptions and additional requirements for generic and similar biological products are also described. The necessary studies will be determined on a case-by-case basis depending on the product
The passage summarizes the major changes to food and drug regulation in the Philippines from the passage of the Food and Drug Administration Act of 2009. Key points:
- The new law created the Food and Drug Administration (FDA) under the Department of Health, headed by a Director-General, to oversee food, drug, medical device, and cosmetic regulation.
- It consolidated regulatory powers over these products under the FDA, affecting two existing agencies. The new law aims to protect public health and establish an effective regulatory system.
- Major changes include new powers for the FDA, reorganization within the Department of Health, and establishment of new units within the FDA. The FDA has since drafted new rules and
The Ministry of Health, Labour and Welfare (MHLW) is Japan's governmental authority that issues regulations and guidelines for pharmaceuticals. The Pharmaceuticals and Medical Devices Agency (PMDA) works with MHLW as Japan's main regulatory body, located in Tokyo. PMDA is responsible for reviewing marketing applications, monitoring post-marketing safety of drugs and devices, and providing compensation for adverse reactions. The drug approval process in Japan involves IND applications reviewed by PMDA and IRB, as well as regulatory reviews and approvals conducted according to a common technical document format.
The document discusses two regulatory agencies - the Therapeutic Goods Administration (TGA) in Australia and the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK. The TGA regulates medicines, medical devices, and chemicals in Australia, ensuring they are safe and effective. It assesses products and places them on the Australian Register of Therapeutic Goods. The MHRA regulates medicines and medical devices in the UK, authorizing their sale and monitoring safety. It assesses products, oversees inspections of manufacturers, and monitors adverse events to safeguard public health. Both agencies aim to balance product access, innovation, and protecting public health.
The FDA regulates food, drugs, medical devices, cosmetics, and other products. It was established in 1930 as part of the US Department of Health and Human Services. The FDA's headquarters is in Maryland and it has many field offices across the US and internationally. Its goals are to ensure consumer safety, increase access to medical products, and improve product quality and manufacturing processes. It regulates a wide range of products from food to drugs to medical devices and ensures they are safe before reaching consumers.
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The document discusses regulations around biocidal products in the European Union. It provides definitions and explains that under the Biocidal Product Regulation, all biocidal products must be authorized before being placed on the market. Applications require approval of both the active substances within biocidal products and of the products themselves, a process that typically takes at least two years. The deadline for existing biocidal products to complete authorization is September 2015.
Definitions according to Drug Regulatory Authority of Pakistan (DRAP medical ...Arooj Abid
This document defines key terms related to medical devices and their regulation in Pakistan. It provides definitions for different types of medical devices including active devices, implants, and in vitro diagnostics. It also defines terms related to the regulation of medical devices such as clinical evaluation, clinical investigation, misbranded devices, notified bodies, and essential principles. The definitions cover a wide range of topics from different types of medical devices to regulatory concepts, organizations, and processes.
This document provides an overview of the US Food and Drug Administration (FDA) in 3 paragraphs. It discusses that the FDA was formed in 1906 and is responsible for regulating foods, drugs, medical devices, and other products. It describes the FDA's structure and responsibilities across its centers and offices. The document also provides brief summaries of the FDA approval processes for drugs, medical devices, and food products.
This document provides information on neutraceuticals and the regulatory framework for neutraceuticals in India. It defines neutraceuticals as food or food components that provide health or medical benefits. The key regulatory body is the Food Safety and Standards Authority of India (FSSAI), which establishes standards for neutraceutical products and licensing. The document outlines labeling requirements, restrictions, and documents needed to apply for a license to manufacture or sell neutraceuticals in India.
The Therapeutic Goods Administration (TGA) regulates therapeutic goods in Australia to protect public health and safety. It evaluates medicines and medical devices to ensure they are safe, effective and of high quality before being supplied in Australia. The TGA is part of the Australian Government Department of Health and has approximately 750 staff from various scientific, medical and administrative backgrounds. It undertakes pre-market evaluations, licenses manufacturers, monitors the market post-approval and maintains the Australian Register of Therapeutic Goods which lists all approved medicines and devices. Higher risk products undergo a rigorous approval process while lower risk goods follow a streamlined listing process.
Regulatory agencies are independent government organizations that create and enforce rules to protect public safety and welfare. Some of the key regulatory agencies described in the document are the Environmental Protection Agency (EPA) which protects the environment, the Federal Communications Commission (FCC) which regulates telecommunications, and the Food and Drug Administration (FDA) which ensures the safety of food and medicine. These agencies have the power to fine or shut down businesses that violate their regulations.
Regulations in India (ASU DTAB, ASU DCC), Regulation of
manufacture of ASU drugs - Schedule Z of Drugs & Cosmetics Act for ASU drugs.
Introduction
Regulatory Requirements
Key function of regulatory agencies
Regulation in India
DRUG TECHNICAL ADVISORY BOARD
Drugs Consultative committee-DCC
Schedule Z of Drugs & Cosmetics Act for ASU drugs.
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.
This document provides information on medical devices used in equine medicine. It defines a medical device as an instrument or article that is used to diagnose, cure, mitigate, treat or prevent disease, and which does not achieve its purpose through chemical action or metabolism. For human medicine, devices are classified from Class I to III based on risk. While the FDA regulates human medical devices, there is no approval process for veterinary devices, though they cannot be misbranded or mislabeled. Practitioners can use veterinary devices for their intended purposes but should be aware they have not been evaluated for safety or efficacy if used as pharmaceuticals.
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.
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.
A regulatory strategy is critical to the commercialization of biomedical technologies. In particular, technologies such as new drugs and medical devices have more regulatory needs, and the strategy should be considered simultaneous to a commercialization pathway.
The Office of Combination Products (OCP) classifies 9 types of combination products based on their constituent parts and primary mode of action. Combination products are assigned to the Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), or Center for Devices and Radiological Health (CDRH) based on whether their primary mode of action is provided by a drug, biological product, or medical device. OCP provides guidance on submitting Request for Designations and classifying new combination products.
Regulatory Authorities for Pharmaceuticals - TGA,MHRA,MCCSanket Shinde
The Therapeutic Goods Administration (TGA) is the regulatory body for therapeutic goods in Australia. The TGA ensures medicines and medical devices available in Australia are safe and effective by conducting pre-market assessment and post-market surveillance. It maintains the Australian Register of Therapeutic Goods which lists all approved therapeutic goods. The TGA regulates medicines and medical devices according to risk level and oversees manufacturing licensing and good practices.
regulation for combination product and medical devicesSNEHADAS123
The document discusses regulations for combination products and medical devices. It begins by providing context on the pharmaceutical industry and need for regulations. Key points include:
- Combination products contain both a drug and medical device component. The FDA assigns a lead center for review based on the primary mode of action.
- Medical devices are defined and examples of products classified as drugs or devices are given. Software can be considered a medical device.
- Regulations provide a framework for safe, effective and quality products. Major regulatory bodies and pathways like 510(k) and PMA are outlined for the US, EU, and India. Recent developments aim to strengthen regulations in India.
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.
This document from the World Health Organization provides an update to the United Nations Consolidated List of pharmaceutical products that have been banned, withdrawn, severely restricted, or not approved by governments. It summarizes regulatory actions taken by 38 governments on 99 pharmaceutical products from 2009-2010 and earlier years. For each product, it provides the chemical name and CAS registry number if available, a summary of regulatory measures, and references to supporting documentation. The list is intended to promote safe and rational use of medicines and complement other WHO publications on drug safety.
The Therapeutic Goods Administration or TGA is the regulatory body for therapeutic goods in Australia.
The TGA is responsible for conducting assessment and monitoring activities to ensure that therapeutic goods available in Australia are of an acceptable standard.
The document summarizes several regulatory agencies that regulate pharmaceutical products around the world. It discusses the roles and functions of the CDSCO in India, FDA in the United States, TGA in Australia, Health Canada, and MHRA in the UK. For each agency, it provides information on their goals, activities related to drug approval and regulation, and key application forms.
Full description of the regulatory process for the medical devices registration in South Korea. It contains information about: classification, substantial equivalence, product license, testing, Korean Good Manufacturing Practice (KGMP)...
Find more on: http://kobridgeconsulting.com/?p=767
Pharma Uptoday Monthly Magazine Volume 5, Issue Aug 2014Sathish Vemula
This document provides a summary of news and regulatory information related to the pharmaceutical industry. Key points include:
- The FDA released its strategic priorities document and is seeking public comments on how to ensure drug safety throughout a product's lifecycle.
- Novartis' Japan unit and a former employee were charged for allegedly manipulating data related to their blood pressure drug Diovan.
- The TGA published an updated summary of fees and is working to implement eCTD submissions for drug applications.
- The FDA filed a complaint seeking to permanently enjoin a California company from distributing vaginal drug products without approval.
- Industry groups in India are concerned about dependence on China for drug APIs and are calling for policies to promote
This document discusses the role and importance of regulatory affairs professionals in the pharmaceutical industry. It notes that regulatory affairs professionals ensure companies comply with relevant laws and regulations, advise on regulatory strategies and requirements, and facilitate the approval and marketing of drugs by communicating with regulatory agencies. Their work is important for developing innovative products and accelerating time to market while ensuring safety, efficacy and compliance.
Best Practice Document on Handling of Market Complaints.pdfTom Aspinall
Market complaints in the pharmaceutical industry refer to issues raised by consumers or regulatory bodies regarding product quality, safety, or marketing practices. These complaints are crucial for maintaining industry standards, ensuring patient safety, and regulatory compliance.
The WHO guideline provides recommendations for six policy interventions that countries can use to manage medicine prices:
1) Regulating mark-ups in the supply chain to incentivize affordable medicines.
2) Exempting essential medicines from taxation to improve access.
3) Replacing cost-plus pricing with alternative strategies like reference pricing.
4) Using external reference pricing as part of a strategy for negotiating prices.
5) Promoting generics through early market entry and multiple strategies to achieve low prices.
6) Using health technology assessment to support pricing decisions and in combination with reference pricing.
Key principles are adopting a combination of policies tailored to the context and making pricing transparent, supported, and regularly reviewed.
Genocide in International Criminal Law.pptxMasoudZamani13
Excited to share insights from my recent presentation on genocide! 💡 In light of ongoing debates, it's crucial to delve into the nuances of this grave crime.
Business law for the students of undergraduate level. The presentation contains the summary of all the chapters under the syllabus of State University, Contract Act, Sale of Goods Act, Negotiable Instrument Act, Partnership Act, Limited Liability Act, Consumer Protection Act.
सुप्रीम कोर्ट ने यह भी माना था कि मजिस्ट्रेट का यह कर्तव्य है कि वह सुनिश्चित करे कि अधिकारी पीएमएलए के तहत निर्धारित प्रक्रिया के साथ-साथ संवैधानिक सुरक्षा उपायों का भी उचित रूप से पालन करें।
This document briefly explains the June compliance calendar 2024 with income tax returns, PF, ESI, and important due dates, forms to be filled out, periods, and who should file them?.
Receivership and liquidation Accounts
Being a Paper Presented at Business Recovery and Insolvency Practitioners Association of Nigeria (BRIPAN) on Friday, August 18, 2023.
The Future of Criminal Defense Lawyer in India.pdfveteranlegal
https://veteranlegal.in/defense-lawyer-in-india/ | Criminal defense Lawyer in India has always been a vital aspect of the country's legal system. As defenders of justice, criminal Defense Lawyer play a critical role in ensuring that individuals accused of crimes receive a fair trial and that their constitutional rights are protected. As India evolves socially, economically, and technologically, the role and future of criminal Defense Lawyer are also undergoing significant changes. This comprehensive blog explores the current landscape, challenges, technological advancements, and prospects for criminal Defense Lawyer in India.
Matthew Professional CV experienced Government LiaisonMattGardner52
As an experienced Government Liaison, I have demonstrated expertise in Corporate Governance. My skill set includes senior-level management in Contract Management, Legal Support, and Diplomatic Relations. I have also gained proficiency as a Corporate Liaison, utilizing my strong background in accounting, finance, and legal, with a Bachelor's degree (B.A.) from California State University. My Administrative Skills further strengthen my ability to contribute to the growth and success of any organization.
Matthew Professional CV experienced Government Liaison
Nz categorisationof products
1. Revised: 1 July 2014
Categorisation of Products
This guide has been prepared to help companies understand the factors that determine the category under which a product is
regulated.
The categorisation of a product is determined by its ingredients, its purpose for use and the manner in which it is presented in
the market.
Ingredients
Products categorised as dietary supplements, supplemented foods, cosmetics, or related products are not permitted to contain
ingredients scheduled as Controlled Drugs under the Misuse of Drugs Act 1975 or scheduled as prescription medicines,
restricted (pharmacist-only) medicines or pharmacy-only medicines under the Medicines Act 1981.
Medsafe's searchable database can be used to check whether an ingredient is scheduled under the Medicines Act. When
searching for a substance in the schedule remember to check synonyms if the initial seach gives a "not found" result.
Lists of Controlled Drugs can be found in Schedules at the end of the Misuse of Drugs Act.
Purpose for use
Therapeutic claims are not permitted for products supplied as dietary supplements, supplemented foods or cosmetics.
Independent advice is available on whether a claim implies a therapeutic purpose. The Association of New Zealand
Advertisers offers a Therapeutic Advertising Pre-vetting Service (TAPS). For a fee an adjudicator will assess labels and
advertising material and advise if it is compliant with NZ legislation. TAPS also offer advice on how statements could be
modified to avoid non-compliance with the Medicines Act 1981. Alternatively there are a number of regulatory affairs
consultants who specialise in advertising compliance. A list is available on this web site.
Another useful resource is the TAPS website. This website contains some guidelines on therapeutic claims and provides
examples of claims that do not imply a therapeutic purpose.
Other sources of information
Distributors wishing to import unprocessed plant or animal material, should contact NZ Biosecurity to determine which import
standards apply.
The New Zealand Customs Service is also able to advise on the requirements for commercial importation.
Copies of all the New Zealand Acts and Regulations discussed above may be downloaded for free from
www.legislation.govt.nz
The following can be used to determine the appropriate regulatory coverage for a product.
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2. Categorisation Guidance
The following table provides categorisation information for various types of product.
The examples that have been selected for inclusion in the table are illustrative of product types that will change categorisation
from 1 July 2014 or product types that lie close to the medicine / medical device interface.
Product Type Category
(from 1 July 2014)
Absorbable intra-ocular and synovial visco-elastic fluids used in surgery Medical device
Artificial tears or saliva
Blood bags with / without anticoagulant / preservative
Bone cement with antibiotic
Catheter with heparin / antibiotic coating
Contact lens lubricants and solutions
Condoms with spermicide / viricide / local anaesthetic
Cryogenic gases
Dental cement with antibiotic / adrenaline
Dermal Fillers (e.g. collagen injections) with / without local anaesthetic included in the formulation
Douches for body "cleaning"
Haemodialysis solutions
Haemostatic agents - collagen and non-medicated Medical device
Haemostatic agents - fibrin Medicine
Hormone eluting intra-uterine contraceptive devices Medicine
Injectable contrast agents for use in diagnostic imaging (e.g PET, CAT, NMR, X-Ray, Ultra-sound) Medicine
Intra-uterine contraceptive devices other than hormone eluting IUCDs (includes copper containing
IUCDs)
Medical device
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3. Product Type Category
(from 1 July 2014)
In-vitro pregnancy tests
Irradiating apparatus
Lubricating gels with / without local anaesthetic included in the formulation
Manuka honey dressings provided the action of the honey is not described as being an antibiotic /
antibacterial
Medicated dressings where the primary purpose of the dressing is to cover and protect the wound and
provide an environment that supports healing (in contrast to being a delivery mechanism for the
medication).
Peritoneal dialysis solutions and substances Medicine
Procedure kits (no medicines included) Medical device
Procedure kits which include an approved medicine in its original pack Medical device
Saline nasal sprays Medical device
Saline for injection Medicine
Solutions for irrigation Medical device
Tamponade solutions for eye surgery Medical device
Tissue adhesives (including fibrin based) Medical device
Toothpastes for sensitive teeth where the mode of action is physical (e.g by blocking open pores).
Fluoride content (if any) must be no greater than that allowed in a general sales medicine
Medical device
Total Parenteral Nutrition (TPN) solutions Medicine
Transdermal patches Medicine
Vascular balloons with / without medicinal coating Medical device
Urea ointment for nail debridement Medical device
Ultrasonic therapy apparatus Medical device
Water for injection Medicine
Requesting a Product Categorisation from Medsafe
If assistance is required in determining whether a product is a medicine or a medical device the sponsor of the product should
collate the following information and submit this to Medsafe together with their request for the categorisation status of the
product.
Name and contact details of the sponsor
Name and location details of the manufacturer
Name of the product
A description of the purpose of the product
Information about the mode(s) of action of the product
A description of the form of the product
Information about any regulatory approvals the product has from other regulators or notified bodies including;
The name of the regulator/notified body
The type of approval granted (CE Mark, FDA 510k, FDA Pre Market Assessment, TGA Registration or Inclusion,
etc)
A copy of the promotional material for the product
URL of a website detailing the product
A copy of the product label
Medsafe may also request further information about the product in order to make a decision.
The above information should be submitted to Medsafe by one of the following methods;
Electronically - by email to devices@moh.govt.nz
Courier - to Medsafe, Level 6, 10 Brandon Street, Wellington, 6011
Post - to Medsafe, PO Box 5013, Wellington, 6145
Definitions
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4. Therapeutic Purpose
Therapeutic purpose - means any of the following purposes, or a purpose in connection with any of the following purposes:
preventing, diagnosing, monitoring, alleviating, treating, curing, or compensating for, a disease, ailment, defect, or injury;
or
a.
influencing, inhibiting, or modifying a physiological process; orb.
testing the susceptibility of persons to a disease or ailment; orc.
influencing, controlling, or preventing conception; ord.
testing for pregnancy; ore.
investigating, replacing, or modifying parts of the human anatomyf.
Medicine -
means any substance or article that -
is manufactured, imported, sold, or supplied wholly or principally for administering to 1 or more human beings for a
therapeutic purpose; and
i.
achieves, or is likely to achieve, its principal intended action in or on the human body by pharmacological,
immunological, or metabolic means; and
ii.
a.
includes any substance or article -
that is manufactured, imported, sold, or supplied wholly or principally for use as a therapeutically active ingredient in
the preparation of any substance or article that falls within paragraph (a); or
i.
of a kind or belonging to a class that is declared by regulations to be a medicine for the purposes of the Medicines
Act; but
ii.
b.
does not include -
a medical device; ori.
any food within the meaning of section 2 of the Food Act 1981; orii.
any radioactive material within the meaning of section 2(1) of the Radiation Protection Act 1965; oriii.
any animal food in which a medicine (within the meaning of paragraph (a) or (b)) is incorporated; oriv.
any animal remedy; orv.
any substance or article of a kind or belonging to a class that is declared by regulations not to be a medicine for the
purposes of the Medicines Act
vi.
c.
Medical Device -
means any device, instrument, apparatus, appliance, or other article that -
is intended to be used in, on, or for human beings for a therapeutic purpose; andi.
does not achieve its principal intended action in or on the human body by pharmacological, immunological, or
metabolic means (but may be assisted in its function by such means); and
ii.
a.
includes a material that -
is intended to be used in or on human beings for a therapeutic purpose; andi.
does not achieve its principal intended action in or on the human body by pharmacological, immunological, or
metabolic means (but may be assisted in its function by such means); and
ii.
b.
also includes -
anything that is intended to be used with a device, instrument, apparatus, appliance, article, or material referred to
in paragraph (a) or (b) to enable the device, instrument, apparatus, appliance, article, or material to be used as its
manufacturer intends; and
i.
any device, instrument, apparatus, appliance, article, or material of a kind or belonging to a class that is declared by
regulations to be a medical device for the purposes of the Medicines Act; but
ii.
c.
does not include a device, instrument, apparatus, appliance, article, or material of a kind or belonging to a class that is
declared by regulations not to be a medical device for the purposes of the Medicines Act
d.
Related Product
A related product is defined in the Medicines Act 1981. A related product is a cosmetic or dentifrice or food in respect of
which a claim is made that the substance or article is effective for a therapeutic purpose. It does not include any medicine.
A product that is used "wholly or principally" for a therapeutic purpose is a medicine. A related product has a therapeutic
purpose that is not its principal purpose (e.g. a fluoride toothpaste, where the principal purpose is to clean the teeth).
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5. Many products at the food-therapeutic product interface are likely to be related products (e.g. a capsule containing vitamins
and minerals where the principal purpose is to supplement the dietary intake of those substances).
Supplemented Food
Supplemented foods are regulated under the Food Act 1981 and are subject to the NZ Food (Supplemented Food)
Standards 2010.
The standards can be downloaded from www.foodsafety.govt.nz.
Dietary Supplement
Dietary supplements are regulated under the Food Act 1981 and are subject to the Dietary Supplements Regulations 1985
(administered by Medsafe). These regulations specify a number of requirements for dietary supplements relating to matters
such as composition, labelling and maximum permitted daily doses for many vitamins and minerals.
Cosmetic
A product is a cosmetic if it is used to beautify, cleanse or protect the hair, skin. teeth or complexion.
Refer to the Cosmetic Products Group Standard 2006, published by the Environmental Protection Authority (EPA) under the
Hazardous Substances and New Organisms (HSNO) legislation.
This group standard includes lists of chemicals whose use in cosmetics is restricted.
It is available from www.epa.govt.nz
Refer also to regulations 22, 24 and 26-36 of the Medicines Regulations 1984 for requirements that apply to cosmetics.
"Therapeutic type" Dose Form
A therapeutic type dose form is a presentation of the product in a form generally used in pharmaceuticals such as tablets,
capsules and controlled amounts of oral liquids or powders.
A product is considered a supplemented food if it is represented as a food that has a substance or substances added to it or
that has been modified in some way to perform a physiological role beyond the provision of nutritive requirement.
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