The document discusses drug safety monitoring in Russia. It outlines the legal and regulatory framework for drug safety monitoring, including key laws and orders. It then describes the drug safety monitoring system in Russia, which involves collecting adverse event reports, analyzing the data, and taking actions like modifying drug labels or suspending approval if risks are identified. For biosimilars, additional pre-clinical and clinical trials are needed to evaluate safety due to their complex nature and potential for immunogenicity. Overall, the document provides an overview of Russia's system for monitoring the safety of drugs, both traditional and biosimilar, after they reach the market.
The Russian Ministry of Industry and Trade reconsidered restrictions on the supply of medical devices for state procurement in July 2014. The restrictions affect state and municipal procurements of medical devices from a closed list. If at least two bids with local products from Russia, Belarus or Kazakhstan are submitted for tender, buyers will be unable to procure medical devices originating from other countries. The local products must be confirmed by a certificate of origin issued by a local authorized agency. Certain categories of medical devices are subject to the restrictions, including syringes, osteosynthesis implants, ECG devices, and surgical instruments.
The Commonwealth of Independent States (CIS) is an intergovernmental organization formed in 1991 by countries of the former Soviet Union. The document discusses pharmaceutical regulations and drug registration procedures in several CIS countries, including Russia, Ukraine, and Kazakhstan. Key aspects summarized include the regulatory authorities responsible for drug approval in each country, the typical registration process and requirements, and post-marketing pharmacovigilance obligations.
Choosing the right facility for clinical trials in RussiaAnton Dulov
This document provides information on conducting clinical trials in Russia. It notes that medical institutions must be accredited by Roszdravnadzor to perform clinical trials. Main medical institutions in central Russia are preferable as they tend to have wider specializations and can perform trials faster. Roszdravnadzor oversees the accreditation process, maintains a list of accredited facilities, and verifies that facilities have the proper licenses and equipment before issuing permission to conduct trials. Facilities must submit documentation to Roszdravnadzor to become accredited and receive approval to perform specific clinical trials.
5 questions on safety reporting for medical devices in CIS regionAlexey Stepanov
This document summarizes safety reporting requirements for medical devices in CIS countries, including Russia, Belarus, Ukraine, and Kazakhstan. It outlines what information must be reported, the regulations requiring reporting, reporting deadlines, and how and where to report. The key information that must be reported includes adverse reactions, undesirable events during usage, circumstances endangering patient or health professional life or health, and device interactions. Regulations and reporting bodies differ by country but generally require reporting within 10-20 days to the relevant health ministry or inspectorate.
The document discusses medical device labeling requirements in Russia. It outlines several key Russian laws and regulations pertaining to medical device registration, customs clearance, advertising, sales, distribution, and use. It emphasizes that labeling must be in Russian and match the information in the registration certificate. It recommends using over-labeling with essential information in Russian as the most common way for foreign manufacturers to comply with labeling language requirements. Failure to properly translate labeling could result in seized products or additional taxes and fees.
The document discusses upcoming harmonization of medical device regulations within the Eurasian Economic Union (EEU) between Russia, Belarus, and Kazakhstan. Key points include:
- A common medical device market within the EEU is expected to launch on January 1, 2016 under new harmonized rules.
- Many regulations still need to be adopted by the end of 2015 to provide guidance for implementation.
- Transition periods and potential delays mean full harmonization may not be achieved immediately.
- Manufacturers will need to reallocate resources to adjust to the new regulatory system over time, including re-registering products under the new rules by 2022.
“Pharmacovigilance in the Republic of Kazakhstan -Peculiarities. Biological medicinal products safety monitoring”
Shows the current pharmacovigilance system and practices in Kazakhstan, with a focus on biotherapeutic medicines
The Russian Ministry of Industry and Trade reconsidered restrictions on the supply of medical devices for state procurement in July 2014. The restrictions affect state and municipal procurements of medical devices from a closed list. If at least two bids with local products from Russia, Belarus or Kazakhstan are submitted for tender, buyers will be unable to procure medical devices originating from other countries. The local products must be confirmed by a certificate of origin issued by a local authorized agency. Certain categories of medical devices are subject to the restrictions, including syringes, osteosynthesis implants, ECG devices, and surgical instruments.
The Commonwealth of Independent States (CIS) is an intergovernmental organization formed in 1991 by countries of the former Soviet Union. The document discusses pharmaceutical regulations and drug registration procedures in several CIS countries, including Russia, Ukraine, and Kazakhstan. Key aspects summarized include the regulatory authorities responsible for drug approval in each country, the typical registration process and requirements, and post-marketing pharmacovigilance obligations.
Choosing the right facility for clinical trials in RussiaAnton Dulov
This document provides information on conducting clinical trials in Russia. It notes that medical institutions must be accredited by Roszdravnadzor to perform clinical trials. Main medical institutions in central Russia are preferable as they tend to have wider specializations and can perform trials faster. Roszdravnadzor oversees the accreditation process, maintains a list of accredited facilities, and verifies that facilities have the proper licenses and equipment before issuing permission to conduct trials. Facilities must submit documentation to Roszdravnadzor to become accredited and receive approval to perform specific clinical trials.
5 questions on safety reporting for medical devices in CIS regionAlexey Stepanov
This document summarizes safety reporting requirements for medical devices in CIS countries, including Russia, Belarus, Ukraine, and Kazakhstan. It outlines what information must be reported, the regulations requiring reporting, reporting deadlines, and how and where to report. The key information that must be reported includes adverse reactions, undesirable events during usage, circumstances endangering patient or health professional life or health, and device interactions. Regulations and reporting bodies differ by country but generally require reporting within 10-20 days to the relevant health ministry or inspectorate.
The document discusses medical device labeling requirements in Russia. It outlines several key Russian laws and regulations pertaining to medical device registration, customs clearance, advertising, sales, distribution, and use. It emphasizes that labeling must be in Russian and match the information in the registration certificate. It recommends using over-labeling with essential information in Russian as the most common way for foreign manufacturers to comply with labeling language requirements. Failure to properly translate labeling could result in seized products or additional taxes and fees.
The document discusses upcoming harmonization of medical device regulations within the Eurasian Economic Union (EEU) between Russia, Belarus, and Kazakhstan. Key points include:
- A common medical device market within the EEU is expected to launch on January 1, 2016 under new harmonized rules.
- Many regulations still need to be adopted by the end of 2015 to provide guidance for implementation.
- Transition periods and potential delays mean full harmonization may not be achieved immediately.
- Manufacturers will need to reallocate resources to adjust to the new regulatory system over time, including re-registering products under the new rules by 2022.
“Pharmacovigilance in the Republic of Kazakhstan -Peculiarities. Biological medicinal products safety monitoring”
Shows the current pharmacovigilance system and practices in Kazakhstan, with a focus on biotherapeutic medicines
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 key drug laws in Pakistan, including the Drugs Act of 1976, rules framed under the Act, the DRAP Act of 2012, and the Pharmacy Act of 1967. It summarizes the purpose and some important sections of each law. The Drugs Act regulates drug import, manufacture, storage, distribution and sale. It establishes various regulatory bodies and sets penalties for violations. The rules framed under the Act cover licensing, registration, advertising and other areas. The DRAP Act established the Drugs Regulatory Authority of Pakistan and regulates biologicals, drugs, medical devices and other therapeutic goods. The Pharmacy Act established pharmacy councils and regulates the profession of pharmacy.
TGA presentation: Legislation and patient access schemes for medicinal cannabisTGA Australia
This presentation provides an update on the current progress of the development of clinical guidance on the use of medicinal cannabis products in Australia.
This presentation provides information about the regulatory system for pharmaceutical manufacturers and GMP inspections in the European Union. It is compiled by Drug Regulations, a nonprofit organization that provides online resources for pharmaceutical professionals. The presentation explains that the EU has a harmonized system where the same rules and procedures apply in all 28 member states, which is overseen by the European Medicines Agency and national competent authorities. Manufacturers supplying products to the EU must comply with Good Manufacturing Practice standards and are subject to regular inspections.
This document outlines provisions for drug registration in China, including:
- The State Food and Drug Administration is responsible for drug registration nationwide and oversees clinical trials, production, and importation of drugs.
- The registration process involves application and review of drugs for safety, efficacy, and quality. It includes clinical trials and inspections of manufacturing facilities.
- Applications are reviewed following principles of openness, fairness and protecting confidential information submitted by applicants.
The document discusses the establishment of a national Pharmacovigillance center in Pakistan to monitor adverse drug reactions and ensure drug safety. It outlines that the center would collect voluntary reports from healthcare professionals and the public on suspected adverse reactions, lack of drug efficacy, and pharmaceutical defects. The center would work to establish standardized Pharmacovigillance processes in Pakistan and expand monitoring to areas like antibiotics resistance, medical devices, and traditional medicines.
Data exclusivity laws grant originator pharmaceutical companies exclusive rights to clinical trial and other registration data submitted to drug regulators for a period of time. This prevents generic companies from relying on the originator's data to gain marketing approval for generic versions. While intended to reward innovation, data exclusivity can delay competition and affordable generic drug access. The TRIPS agreement requires protection of undisclosed drug data, but does not mandate data exclusivity. Less restrictive alternatives that still comply with TRIPS, such as data protection only, are preferable from a public health perspective.
This document outlines guidelines for filing applications using an Integrated Application Form adopted by the Philippines' Food and Drug Administration (FDA) to streamline the application process. The form was created to comply with laws mandating improved efficiency and accountability in government services. It consolidates requirements for various FDA authorizations like licenses and permits onto a single electronic form. Applicants must submit documentary requirements digitally, pay fees, and provide hard copies of certain documents to complete the application process based on a scheduled intake procedure.
Contents:
History
DRAP
Composition of DRAP
Function of DRAP
Policy board
Funds and budget of DRAP
Real picture of DRAP
Other agencies
References
History Of Authorities
What Is Drug Regulatory Authority
Drug Regulatory Authority of Pakistan (DRAP) has been established in NOV13,2012 for effective coordination and enforcement of the Drugs Act, 1976.
The Drug Regulatory Authority of Pakistan (DRAP) is an autonomous body working under the administrative control of Ministry of National Health Services.
The Authority is expected to regulate, manufacture, import, export, storage, distribution and sale of therapeutic goods.
What Is Drug Regulatory Authority,…
The authority may set up its establishments including sub-offices and laboratories at province capital and such other places from time to time.
The existing Federal Drug Control Administration(FDCA) and sub offices set up in all provinces are called Central Drug Laboratory
For example;
National Control Laboratory on Biological, Karachi
Federal Drug Surveillance Laboratory, Islamabad
Composition Of DRAP
Chief executive officer
Director Pharmaceutical Evaluations and Registration
Director Drug Licensing
Director Quality Assurance and Laboratory Testing
Director Medical Devices and Medicated Cosmetics
Director Biological Drugs
Composition Of DRAP,….
Director Controlled Drugs
Director Health and OTC Products (non-drugs)
Director Costing and Pricing
Director Budget and Accounts
Director Administration, Human Resource and Logistics
Director Legal Affairs
Director Management Information Services
Power And Function Of DRAP
Evaluation and Registration of pharmaceutical drugs, medical devices and medicated cosmetics, alternative medicines And Licensing of Drug Manufacturing facilities.
Regulation of controlled drugs and biological drugs.
Policy board
DRA will work under the Policy board which consists of 15 members.
Chair person of Board will be Secretary of Federal Health Division
Members will consist of Chief Executive of Agency, Health Secretary of all provinces.
Functions of policy board
Monitor and supervise all function of the DRAP.
Approve the budget of the DRAP.
Determine all fees and leaves.
Funds And Budgets
Loans and grants from the national and international agencies received by the federal government and provincial government to finance the function of the authority.
Grat-in aid in term of salaries and retirements benefits of the existing staff provided by the federal government.
Charges and fees collected by the authority to recover the cost of regulated activities
Funds And Budgets……………
Central research fund collected from pharmaceutical industry.
The authority shall, in respect of each financial year prepare an annual budget for approval from board and shall sent to the federal government for appropriate provision and allocation.
Facts About DRAP
Dr Hussein, regional
To compare filing process of NDA of different countries of India, US and Euro...Aakashdeep Raval
To compare filing process of NDA of different countries of India, US and Europe.
B) Preparation of global list documents of registration of IND and NDA as per USFDA and Europe.
The impact on information flow, safety and labelling documents, document granularity, naming of documents and metadata, the preparation and submissions of XEVMPD dossiers
SUGAM is an online portal launched by CDSCO that allows stakeholders to apply for licenses, permits, and approvals for drugs, medical devices, diagnostics, cosmetics, and clinical trials. Through SUGAM, applicants can submit applications online, track application status, respond to queries, and download approvals issued by CDSCO. The portal provides a single window for applying for licenses like Form 41 registration certificates, import licenses under Form 10, test licenses for clinical trials, and BE NOC for new drugs. Users must register on the portal and can then login to submit applications and check status.
The new Clinical Trial Regulation (No. 536/2014) will come into effect in 2018 and replace the current Directive 2001/20/EC. The Regulation aims to streamline the clinical trial application process and increase transparency. Key changes include a single EU portal for electronic submission, a coordinated review process with defined timelines, and increased public access to trial information. There will be a three year transition period for ongoing trials to transition to the new system. Ivowen is available to support companies with regulatory submissions and compliance under the new Regulation.
The document summarizes the key proposed amendments to the Drugs and Cosmetics Act from the 2013 bill. It outlines the establishment of a new Central Drugs Authority to regulate the import, manufacture, and sale of drugs, cosmetics and medical devices. It also creates new chapters on clinical trials, requiring permission and registration for any trials. Penalties are established for violations like conducting unauthorized trials or failing to provide proper compensation. The bill aims to modernize drug regulation in India through the new oversight body and additional rules for clinical research.
This presentation is about the basic responsibilities and functions of CDSCO explaining the regulatory body's constitution, comprising of functions of state licensing authority and port offices covering the guidelines for new drug approval process, clinical trails and medical devices. this presentation also give a basic note on SUGAM
The document discusses regulatory requirements and procedures for approval of new vaccines in India. It provides definitions of key terms like drugs, new drugs and vaccines. It describes the information and data required to be submitted for approval, including safety and efficacy data from clinical trials. It also discusses post-marketing surveillance requirements and procedures for investigating and reporting adverse events following immunization.
The Central Drugs Standard Control Organisation (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. It is responsible for approving new drugs, medical devices, and clinical trials. CDSCO has headquarters in New Delhi and is overseen by the Drug Controller General of India. It has various zonal and sub-zonal offices that perform GMP audits, inspections, and quality control tests. CDSCO uses a multi-step process to approve clinical trials, drugs, cosmetics, and medical devices that involves submitting documents and gaining permission from the DCGI. It also has an online portal called SUGAM to streamline the application process.
Pharmaceutical Licecnsing authorites of indiaAtul Bhombe
Central Drug Standard Control Organisation (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. It regulates the import of drugs, approves new drugs and clinical trials. CDSCO works with six zonal offices, seven sub-zonal offices, and thirteen port/airport offices. The Drug Controller General of India, who is responsible for new drug, medical device, and clinical trial approvals, advises CDSCO. At the state level, State Licensing Authorities regulate and control the licensing of drug manufacturing, distribution, and sale within the state.
This document provides information and instructions for using the Electronic Drug Price Monitoring System (EDPMS), which monitors drug prices and inventories in the Philippines. It summarizes the laws requiring EDPMS reporting, the EDPMS reporting process, sanctions for non-compliance, and contact information for technical support. Pharmaceutical suppliers must upload drug price and inventory data monthly to EDPMS to participate in government drug procurement bids. The document provides step-by-step instructions for downloading, installing, and using the standalone EDPMS software to enter and upload local data files.
Innovator Selection (Reference Medicinal Product) by Mr. Pankaj DhapadePankaj Dhapade
It contains the definitions of Reference Medicinal Product, Generic Medicinal Product and European Reference Medicinal Product along with their Regulatory requirements in Europe.
Regulatory requirnment and approval procedure of drugs in japan pptsandeep bansal
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
“The regulatory landscape for biotech products in Ukraine”
Illustrates the current norms in place in Ukraine for the marketing authorization of pharmaceutical products and the dossier requirements for biotherapeutics & biosimilars
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 key drug laws in Pakistan, including the Drugs Act of 1976, rules framed under the Act, the DRAP Act of 2012, and the Pharmacy Act of 1967. It summarizes the purpose and some important sections of each law. The Drugs Act regulates drug import, manufacture, storage, distribution and sale. It establishes various regulatory bodies and sets penalties for violations. The rules framed under the Act cover licensing, registration, advertising and other areas. The DRAP Act established the Drugs Regulatory Authority of Pakistan and regulates biologicals, drugs, medical devices and other therapeutic goods. The Pharmacy Act established pharmacy councils and regulates the profession of pharmacy.
TGA presentation: Legislation and patient access schemes for medicinal cannabisTGA Australia
This presentation provides an update on the current progress of the development of clinical guidance on the use of medicinal cannabis products in Australia.
This presentation provides information about the regulatory system for pharmaceutical manufacturers and GMP inspections in the European Union. It is compiled by Drug Regulations, a nonprofit organization that provides online resources for pharmaceutical professionals. The presentation explains that the EU has a harmonized system where the same rules and procedures apply in all 28 member states, which is overseen by the European Medicines Agency and national competent authorities. Manufacturers supplying products to the EU must comply with Good Manufacturing Practice standards and are subject to regular inspections.
This document outlines provisions for drug registration in China, including:
- The State Food and Drug Administration is responsible for drug registration nationwide and oversees clinical trials, production, and importation of drugs.
- The registration process involves application and review of drugs for safety, efficacy, and quality. It includes clinical trials and inspections of manufacturing facilities.
- Applications are reviewed following principles of openness, fairness and protecting confidential information submitted by applicants.
The document discusses the establishment of a national Pharmacovigillance center in Pakistan to monitor adverse drug reactions and ensure drug safety. It outlines that the center would collect voluntary reports from healthcare professionals and the public on suspected adverse reactions, lack of drug efficacy, and pharmaceutical defects. The center would work to establish standardized Pharmacovigillance processes in Pakistan and expand monitoring to areas like antibiotics resistance, medical devices, and traditional medicines.
Data exclusivity laws grant originator pharmaceutical companies exclusive rights to clinical trial and other registration data submitted to drug regulators for a period of time. This prevents generic companies from relying on the originator's data to gain marketing approval for generic versions. While intended to reward innovation, data exclusivity can delay competition and affordable generic drug access. The TRIPS agreement requires protection of undisclosed drug data, but does not mandate data exclusivity. Less restrictive alternatives that still comply with TRIPS, such as data protection only, are preferable from a public health perspective.
This document outlines guidelines for filing applications using an Integrated Application Form adopted by the Philippines' Food and Drug Administration (FDA) to streamline the application process. The form was created to comply with laws mandating improved efficiency and accountability in government services. It consolidates requirements for various FDA authorizations like licenses and permits onto a single electronic form. Applicants must submit documentary requirements digitally, pay fees, and provide hard copies of certain documents to complete the application process based on a scheduled intake procedure.
Contents:
History
DRAP
Composition of DRAP
Function of DRAP
Policy board
Funds and budget of DRAP
Real picture of DRAP
Other agencies
References
History Of Authorities
What Is Drug Regulatory Authority
Drug Regulatory Authority of Pakistan (DRAP) has been established in NOV13,2012 for effective coordination and enforcement of the Drugs Act, 1976.
The Drug Regulatory Authority of Pakistan (DRAP) is an autonomous body working under the administrative control of Ministry of National Health Services.
The Authority is expected to regulate, manufacture, import, export, storage, distribution and sale of therapeutic goods.
What Is Drug Regulatory Authority,…
The authority may set up its establishments including sub-offices and laboratories at province capital and such other places from time to time.
The existing Federal Drug Control Administration(FDCA) and sub offices set up in all provinces are called Central Drug Laboratory
For example;
National Control Laboratory on Biological, Karachi
Federal Drug Surveillance Laboratory, Islamabad
Composition Of DRAP
Chief executive officer
Director Pharmaceutical Evaluations and Registration
Director Drug Licensing
Director Quality Assurance and Laboratory Testing
Director Medical Devices and Medicated Cosmetics
Director Biological Drugs
Composition Of DRAP,….
Director Controlled Drugs
Director Health and OTC Products (non-drugs)
Director Costing and Pricing
Director Budget and Accounts
Director Administration, Human Resource and Logistics
Director Legal Affairs
Director Management Information Services
Power And Function Of DRAP
Evaluation and Registration of pharmaceutical drugs, medical devices and medicated cosmetics, alternative medicines And Licensing of Drug Manufacturing facilities.
Regulation of controlled drugs and biological drugs.
Policy board
DRA will work under the Policy board which consists of 15 members.
Chair person of Board will be Secretary of Federal Health Division
Members will consist of Chief Executive of Agency, Health Secretary of all provinces.
Functions of policy board
Monitor and supervise all function of the DRAP.
Approve the budget of the DRAP.
Determine all fees and leaves.
Funds And Budgets
Loans and grants from the national and international agencies received by the federal government and provincial government to finance the function of the authority.
Grat-in aid in term of salaries and retirements benefits of the existing staff provided by the federal government.
Charges and fees collected by the authority to recover the cost of regulated activities
Funds And Budgets……………
Central research fund collected from pharmaceutical industry.
The authority shall, in respect of each financial year prepare an annual budget for approval from board and shall sent to the federal government for appropriate provision and allocation.
Facts About DRAP
Dr Hussein, regional
To compare filing process of NDA of different countries of India, US and Euro...Aakashdeep Raval
To compare filing process of NDA of different countries of India, US and Europe.
B) Preparation of global list documents of registration of IND and NDA as per USFDA and Europe.
The impact on information flow, safety and labelling documents, document granularity, naming of documents and metadata, the preparation and submissions of XEVMPD dossiers
SUGAM is an online portal launched by CDSCO that allows stakeholders to apply for licenses, permits, and approvals for drugs, medical devices, diagnostics, cosmetics, and clinical trials. Through SUGAM, applicants can submit applications online, track application status, respond to queries, and download approvals issued by CDSCO. The portal provides a single window for applying for licenses like Form 41 registration certificates, import licenses under Form 10, test licenses for clinical trials, and BE NOC for new drugs. Users must register on the portal and can then login to submit applications and check status.
The new Clinical Trial Regulation (No. 536/2014) will come into effect in 2018 and replace the current Directive 2001/20/EC. The Regulation aims to streamline the clinical trial application process and increase transparency. Key changes include a single EU portal for electronic submission, a coordinated review process with defined timelines, and increased public access to trial information. There will be a three year transition period for ongoing trials to transition to the new system. Ivowen is available to support companies with regulatory submissions and compliance under the new Regulation.
The document summarizes the key proposed amendments to the Drugs and Cosmetics Act from the 2013 bill. It outlines the establishment of a new Central Drugs Authority to regulate the import, manufacture, and sale of drugs, cosmetics and medical devices. It also creates new chapters on clinical trials, requiring permission and registration for any trials. Penalties are established for violations like conducting unauthorized trials or failing to provide proper compensation. The bill aims to modernize drug regulation in India through the new oversight body and additional rules for clinical research.
This presentation is about the basic responsibilities and functions of CDSCO explaining the regulatory body's constitution, comprising of functions of state licensing authority and port offices covering the guidelines for new drug approval process, clinical trails and medical devices. this presentation also give a basic note on SUGAM
The document discusses regulatory requirements and procedures for approval of new vaccines in India. It provides definitions of key terms like drugs, new drugs and vaccines. It describes the information and data required to be submitted for approval, including safety and efficacy data from clinical trials. It also discusses post-marketing surveillance requirements and procedures for investigating and reporting adverse events following immunization.
The Central Drugs Standard Control Organisation (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. It is responsible for approving new drugs, medical devices, and clinical trials. CDSCO has headquarters in New Delhi and is overseen by the Drug Controller General of India. It has various zonal and sub-zonal offices that perform GMP audits, inspections, and quality control tests. CDSCO uses a multi-step process to approve clinical trials, drugs, cosmetics, and medical devices that involves submitting documents and gaining permission from the DCGI. It also has an online portal called SUGAM to streamline the application process.
Pharmaceutical Licecnsing authorites of indiaAtul Bhombe
Central Drug Standard Control Organisation (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. It regulates the import of drugs, approves new drugs and clinical trials. CDSCO works with six zonal offices, seven sub-zonal offices, and thirteen port/airport offices. The Drug Controller General of India, who is responsible for new drug, medical device, and clinical trial approvals, advises CDSCO. At the state level, State Licensing Authorities regulate and control the licensing of drug manufacturing, distribution, and sale within the state.
This document provides information and instructions for using the Electronic Drug Price Monitoring System (EDPMS), which monitors drug prices and inventories in the Philippines. It summarizes the laws requiring EDPMS reporting, the EDPMS reporting process, sanctions for non-compliance, and contact information for technical support. Pharmaceutical suppliers must upload drug price and inventory data monthly to EDPMS to participate in government drug procurement bids. The document provides step-by-step instructions for downloading, installing, and using the standalone EDPMS software to enter and upload local data files.
Innovator Selection (Reference Medicinal Product) by Mr. Pankaj DhapadePankaj Dhapade
It contains the definitions of Reference Medicinal Product, Generic Medicinal Product and European Reference Medicinal Product along with their Regulatory requirements in Europe.
Regulatory requirnment and approval procedure of drugs in japan pptsandeep bansal
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
“The regulatory landscape for biotech products in Ukraine”
Illustrates the current norms in place in Ukraine for the marketing authorization of pharmaceutical products and the dossier requirements for biotherapeutics & biosimilars
This document discusses the evolution of regulations for biosimilar medicines in Russia. It notes that while Russia's regulations have improved, biosimilars are still evaluated similarly to generics rather than having distinct guidelines. The document calls for developing scientific guidelines for evaluating nine groups of biosimilars based on international practices and research. It acknowledges challenges like intellectual property and developing distinct timelines for biosimilar approval. Creating permanent improvement systems for drug regulation is proposed as a long-term solution.
“Clinical aspects of Interchangeability, substitution and therapeutic switch of Biological Medicinal Products. From the Medical Community Point of View”
Provides an overview of the concerns around interchangeability and automatic substitution from the perspective of the physicians and the patients
Japan drug and cosmetics regulation.pdfBhavikaAPatel
The Pharmaceuticals and Medical Devices Agency (PMDA) is the main regulatory body for pharmaceuticals and medical devices in Japan. It was established in 2004 to review drugs and medical devices, monitor post-marketing safety, and provide regulatory services. PMDA conducts reviews of clinical trial applications, new drug applications, and medical device applications to evaluate safety, efficacy, and quality. It aims to protect public health while facilitating efficient development of drugs and devices. PMDA's reviews and consultations are a major part of bringing new pharmaceuticals and medical technologies to the Japanese population.
The Investigational Medicinal Product Dossier (IMPD) provides key data about investigational drugs used in clinical trials in the European Union. It includes summaries of quality, manufacturing, non-clinical, and previous clinical data. The IMPD aims to harmonize information requirements for clinical trial authorization across EU member states. It can take a full or simplified format depending on previous assessments. In addition to the IMPD, other documents like the clinical trial protocol, informed consent form, and investigator's brochure must be submitted for approval to conduct a clinical trial.
Crown Medical Research and Pharmaceutical Sciences College of Canada.
Achieve your career goals in a short period of time with a very competitive education and get Canadian experience with the highest quality of supervised training.
Crown Medical Research and Pharmaceutical Sciences College of Canada offers opportunities to expand your experience beyond the classroom and support them with guidance on career opportunities.
Our professors, consultants, and course developers are recognized leaders in professional development and training in the field of pharmaceutical, natural health products, quality assurance and quality control, regulatory affairs and submissions, pharmacovigilance and drug safety reporting, clinical research, cosmetics, food sciences, biopharmaceutical, and health care policy and services management.
We strive to continuously evolve and expand our programs in an attempt to respond effectively to changing technologies and workforce demands in the industry. It is with this strategy that our programs will prepare our learners for their future.
When attending our college, you will be exposed to highly qualified professionals and professors as well as students with diverse backgrounds and proven professional abilities seeking to improve their skill set and employment outlook.
We are located at Richmond Hill, in the Greater Toronto Area, that is one of the 3 biggest financial and social center in North America. This gives learners access to the head quarters of many industries and to be exposed to personal, and professional growth opportunities.
Our college offers academic counseling program through one-on-one meetings with professors and collaborators and we offer faculty-mentoring program to assist students in improving their learning and working strategies for reaching faster their career goals.
When you are considering to enroll in a certificate course offered by our college, please explore the program information on the website and contact us for a one-on-one mentoring meeting, to visit the campus, and to get a career consultation at any time. Our intensive courses start every month and our learners can start their program with us at any time during the year.
1. This Circular provides for:
a) Documentation requirements, procedures for issuance, renewal, revision and revocation of the marketing authorization of modern medicines, vaccines, biologicals, herbal drugs and medicinal materials (including active ingredients, semi-finished herbal ingredients, excipients, and capsule shells) for human use in Vietnam;
b) Required clinical data for assurance of safety and efficacy in the application;
c) Requirements for exemption from clinical trial or certain stages thereof in Vietnam; drugs that have to undergo Stage 4 clinical trial;
d) Rules for validation of marketing authorization applications (hereinafter referred to as “marketing application”) for drugs/medicinal materials, renewal and revision thereof;
đ) Rules for validation of applications for license to import drugs that are yet to be approved for marketing authorization (hereinafter referred to as “unapproved drugs”) in the cases specified in Point a Clause 43 Article 5 of Decree No. 155/2018/ND-CP dated November 12, 2018 providing amendments to regulations on business conditions under state management of the Ministry of Health of Vietnam (hereinafter referred to as “Decree No. 155/2018/ND-CP”);
e) Rules for organization and operation of Marketing Authorization Advisory Board (hereinafter referred to as “the Advisory Board”);
g) Procedures for validation of marketing applications, renewal and revision thereof; Procedures for validation of applications for the license to import unapproved drugs.
Ministry of health labour and welfare (mhlw)MUGDHAANAVATTI
The document provides information about the Ministry of Health, Labour and Welfare (MHLW) in Japan. It discusses the following key points:
1. MHLW was established in 2001 by merging the Ministry of Health and Welfare and Ministry of Labor. It regulates pharmaceuticals, medical devices, health insurance, and more.
2. MHLW is made up of various bureaus, councils, affiliated institutions, and local branches. It oversees areas like health policy, medical care, food safety, employment security, and pensions.
3. The Pharmaceutical and Medical Devices Agency was established in 2004 to conduct drug and device approval reviews and post-marketing surveillance to ensure public health.
Medical device management in china and latest regulatory updates_EdwinCIRS China
Currently, China is one of the world's most promising markets for medical devices, which on the back of its vast market size, offers huge potential to medical device companies. All medical devices marketed or sold for use in China must be registered with China Food and Drug Administration (CFDA).
This document summarizes key aspects of Azerbaijan's law on medicines:
- It defines legal principles for dealing with medicines and medical facilities in Azerbaijan, regulating related relations.
- Key terms related to medicines are defined, including medicines, drugs, active substances, original medicines, generics, and more.
- The main duties of the state regarding medicines include guaranteeing access, developing programs, research, assistance programs, and more.
- State regulation methods include licensing, registration, certification, and quality control. The executive authority carries out various regulatory roles.
- Licensing is required for pharmaceutical activities like production, wholesale, and retail sale of medicines.
- Import, production, sale and use of medicines
This document summarizes the development of regulatory procedures for biological medicines in Russia. It discusses the establishment of formal institutions in Russian healthcare, including relevant laws and strategies. It outlines the main areas of regulation, including modifications to pharmaceutical laws, the development of conceptual frameworks for different drug types, and harmonization with international legislation. It also examines the need to precisely define biological and biosimilar medicines in regulations. The document provides an overview of the Scientific Centre for Expert Evaluation of Medicinal Products, which plays a key role in the registration and evaluation of drugs in Russia.
Circular 03/2020/TT-BYT issued January 22, 2020: Amendments to some Articles of the Circular No. 11/2018/TT-BYT dated May 04, 2018 of the Minister of Health on quality of pharmaceutical products and pharmaceutical starting materials
The document outlines a pharmacovigilance workshop, including definitions of pharmacovigilance, the need for monitoring drug safety post-approval, and the pharmacovigilance system process of collecting, evaluating and taking action on adverse drug reactions. The workshop introduction discusses educational activities in Croatia to increase healthcare professional reporting of adverse reactions.
Presentation: Spotlight on prescription medicine post-market reformsTGA Australia
An overview of reform initiatives relevant to prescription medicines pharmacovigilance arising from the Review of Medicines and Medical Devices Regulation.
The document discusses the status and prospects of China's Licensed Pharmacist Qualification System. It provides a general introduction to the system, including its development, management structure, examination process, registration requirements, and the roles and responsibilities of licensed pharmacists. It then compares key differences between China's system and that of the US. Finally, it outlines the future prospects of the system in China as the economy develops and public demand for healthcare increases.
Similar to 33. Topical issues of monitoring of safety of medicines. Focus on biosimilars (20)
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 1: Current Regulatory Landscape & Initiatives Against Fake Medicines
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session4: Collaboration within and between countries
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 4: Collaboration within and between countries
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 4: Collaboration within and between countries
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 3: Practices and Technologies for Prevention, Detection, Control and Monitoring of Fake Medicines.
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 3: Practices and Technologies for Prevention, Detection, Control and Monitoring of Fake Medicines
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 2: Supply Chain Integrity
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 2: Supply Chain Integrity
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 1: Current Regulatorz Landscape & Initiatives Against Fake Medicines
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
The document discusses psoriasis, a chronic skin condition affecting over 125 million people worldwide. Psoriasis causes thickened, red, scaly skin patches that often itch and bleed. It can also cause joint pain and increase risks for other health issues. The document outlines pharmaceutical company efforts to develop new drug treatments for psoriasis, including topical treatments, biologics, and oral medications currently in clinical trials. It emphasizes the need for comprehensive care that coordinates treatment from specialists and considers patients' needs to best manage psoriasis as a chronic condition.
The document provides an overview of the International Psoriasis Council (IPC) and their partnership with ILDS and IFPA to execute the Global Psoriasis Atlas project. The IPC is a nonprofit organization comprised of the world's leading experts in psoriasis. They aim to advance knowledge of psoriasis and enhance patient care through research, education, and clinical practice guidelines. The document notes that worldwide prevalence and incidence of psoriasis is poorly understood currently. The Global Psoriasis Atlas project aims to address this through collecting epidemiological data on psoriasis prevalence, burden, and natural history across countries to inform policy and improve care.
IFPMA Geneva Pharma Forum on 9 May 2014
Bringing Psoriasis into the Light
Presentation of Professor Mahira Hamdy El Sayed
Dermatology and Venereology, Ain Shams University
David K. Robinson, Ph. D.Vice President, BiologicsHead and Executive Director, Biologics and Vaccines CMC RegulatoryMerck & Co, Inc.
Presenting on behalf of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA)WCBP CASS, Washington DC, USAJanuary 2014
This document is comprised of copyright notices from the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) spanning the years 2014 through 2018, suggesting it contains content owned by IFPMA over those years. No other substantive information is provided in the document.
More from International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) (20)
- Video recording of this lecture in English language: https://youtu.be/kqbnxVAZs-0
- Video recording of this lecture in Arabic language: https://youtu.be/SINlygW1Mpc
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Adhd Medication Shortage Uk - trinexpharmacy.comreignlana06
The UK is currently facing a Adhd Medication Shortage Uk, which has left many patients and their families grappling with uncertainty and frustration. ADHD, or Attention Deficit Hyperactivity Disorder, is a chronic condition that requires consistent medication to manage effectively. This shortage has highlighted the critical role these medications play in the daily lives of those affected by ADHD. Contact : +1 (747) 209 – 3649 E-mail : sales@trinexpharmacy.com
Osteoporosis - Definition , Evaluation and Management .pdfJim Jacob Roy
Osteoporosis is an increasing cause of morbidity among the elderly.
In this document , a brief outline of osteoporosis is given , including the risk factors of osteoporosis fractures , the indications for testing bone mineral density and the management of osteoporosis
Integrating Ayurveda into Parkinson’s Management: A Holistic ApproachAyurveda ForAll
Explore the benefits of combining Ayurveda with conventional Parkinson's treatments. Learn how a holistic approach can manage symptoms, enhance well-being, and balance body energies. Discover the steps to safely integrate Ayurvedic practices into your Parkinson’s care plan, including expert guidance on diet, herbal remedies, and lifestyle modifications.
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
TEST BANK For An Introduction to Brain and Behavior, 7th Edition by Bryan Kol...rightmanforbloodline
TEST BANK For An Introduction to Brain and Behavior, 7th Edition by Bryan Kolb, Ian Q. Whishaw, Verified Chapters 1 - 16, Complete Newest Versio
TEST BANK For An Introduction to Brain and Behavior, 7th Edition by Bryan Kolb, Ian Q. Whishaw, Verified Chapters 1 - 16, Complete Newest Version
TEST BANK For An Introduction to Brain and Behavior, 7th Edition by Bryan Kolb, Ian Q. Whishaw, Verified Chapters 1 - 16, Complete Newest Version
Promoting Wellbeing - Applied Social Psychology - Psychology SuperNotesPsychoTech Services
A proprietary approach developed by bringing together the best of learning theories from Psychology, design principles from the world of visualization, and pedagogical methods from over a decade of training experience, that enables you to: Learn better, faster!
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptxHolistified Wellness
We’re talking about Vedic Meditation, a form of meditation that has been around for at least 5,000 years. Back then, the people who lived in the Indus Valley, now known as India and Pakistan, practised meditation as a fundamental part of daily life. This knowledge that has given us yoga and Ayurveda, was known as Veda, hence the name Vedic. And though there are some written records, the practice has been passed down verbally from generation to generation.
TEST BANK For Community Health Nursing A Canadian Perspective, 5th Edition by...Donc Test
TEST BANK For Community Health Nursing A Canadian Perspective, 5th Edition by Stamler, Verified Chapters 1 - 33, Complete Newest Version Community Health Nursing A Canadian Perspective, 5th Edition by Stamler, Verified Chapters 1 - 33, Complete Newest Version Community Health Nursing A Canadian Perspective, 5th Edition by Stamler Community Health Nursing A Canadian Perspective, 5th Edition TEST BANK by Stamler Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Pdf Chapters Download Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Pdf Download Stuvia Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Study Guide Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Ebook Download Stuvia Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Questions and Answers Quizlet Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Studocu Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Quizlet Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Stuvia Community Health Nursing A Canadian Perspective, 5th Edition Pdf Chapters Download Community Health Nursing A Canadian Perspective, 5th Edition Pdf Download Course Hero Community Health Nursing A Canadian Perspective, 5th Edition Answers Quizlet Community Health Nursing A Canadian Perspective, 5th Edition Ebook Download Course hero Community Health Nursing A Canadian Perspective, 5th Edition Questions and Answers Community Health Nursing A Canadian Perspective, 5th Edition Studocu Community Health Nursing A Canadian Perspective, 5th Edition Quizlet Community Health Nursing A Canadian Perspective, 5th Edition Stuvia Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Pdf Chapters Download Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Pdf Download Stuvia Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Study Guide Questions and Answers Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Ebook Download Stuvia Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Questions Quizlet Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Studocu Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Quizlet Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Stuvia
TEST BANK For Community Health Nursing A Canadian Perspective, 5th Edition by...
33. Topical issues of monitoring of safety of medicines. Focus on biosimilars
1. S.V. Glagolev, Deputy Division Head, Head, Medical Product Efficacy and Safety
Monitoring Department, Medical Product Quality Public Control Division,
Federal Service for Surveillance in Healthcare
V.А. Polivanov, Head, Center for Drug Efficient, Safe and Reasonable Use
Monitoring at the Information and Methodical Center for Appraisal,
Accounting for and Analysis of Medical Facilities (IMCAAAMF), Federal Service
for Surveillance in Healthcare
Federal Service for Surveillance in Healthcare
Local Drug Safety
Monitoring Issues
Biosimilar Safety
Monitoring Issues
3. Legal and Regulatory Framework of the Drug Safety
Monitoring
•Federal Drug Circulation Law dated April 12, 2010, No. 61-FZ
•Resolution of the Government of the Russian Federation dated June 30, 2004, No. 323, On Approval
of the Regulations on the Federal Service for Surveillance in Healthcare and Social Development, in
the version of the Russian Government Resolution dated August 20, 2010, No. 650, On Making
Amendments to Certain Acts of the Government of the Russian Federation in connection with
Adoption of the Federal Drug Circulation Law
•Order of the Ministry of Healthcare and Social Development of the Russian Federation dated August
26, 2010, No. 757n, On Approval of the Procedure for Safety Monitoring of Medicinal Drugs,
Registration of Adverse Effects, Severe Adverse Effects, Unforeseeable Adverse Effects in Application
of Medicinal Drugs (registered by the Ministry of Justice of Russia on August 31, 2010, No. 8324)
•Order of the Ministry of Healthcare and Social Development of the Russian Federation dated August
26, 2010, No. 758n, On Approval of the Procedure for Medicinal Drug Application Suspension
(registered by the Ministry of Justice of Russia on August 31, 2010, No. 18325)
•Order of the Ministry of Healthcare and Social Development of the Russian Federation dated August
26, 2010, No. 749n, On Approval of the Format of the Document Containing the Safety Monitoring
Results for Medicinal Drugs to Confirm their State Registration (registered by the Ministry of Justice
of Russia on August 31, 2010, No. 18304)
•National Standard, Good Clinical Practice. State Standard R 52379-2005, as approved by Order of the
Federal Agency for Technical Regulation and Metrology dated September 27, 2005, no. 232-s.
4. Changes in Drug Safety Monitoring Regulation in 2010
• The duty of the pharmaceutical entities to notify the competent governmental authority of severe or
unforeseeable adverse effects or drug interactions is established
• The governmental function of drug safety monitoring is vested with the Federal Service for Surveillance in
Healthcare
• The timing for filing information on adverse drug effects to the Federal Service for Surveillance in
Healthcare is determined (15 calendar days)
• The need in and timing of filing regular drug safety reports to Federal Service for Surveillance in
Healthcare was established
• The option of drug state registration suspension or cancellation based on the safety monitoring results is
envisaged
• The new regulation on state registration cancellation, if the applicant does not provide the information
that may entail the need in making amendments to the registration file (within 30 days from occurrence of
such changes), is introduced
• The requirement to file the safety monitoring results with the Ministry of Healthcare and Social
Development of the Russian Federation in confirming drug registration is introduced
5. Drug Safety Monitoring
FSSH’s computerized
information system
Regional drug safety
monitoring centers
DQCC
IMCAAANF (FSU)
at FSSH
1.Input of incoming information to
FSSH’s computerized information
system (CIS) and its analysis
2.Sending of information on adverse
drug reactions to drug registration
applicants
3.Arranging for information appraisal
at FSSH’s IMCAAAMF FSU, including
request for assessment of the causal
relationship as well as the opinions on
legal cases
4. Arranging for quality appraisal of the
drugs that caused adverse reaction (if
necessary)
5.Coordination of operations of the
regional drug safety monitoring centers
as concerns investigation into the
instances of adverse reactions.
6.Review of scientific publications and
decisions of foreign regulatory
authorities
Resolutions
• to modify the drug instruction
• to suspend application
•to withdraw the drug
•to resume the drug application
Ministry of
Healthcare of
the Russian Federation
Recommendations based on
monitoring results
On making amendments to the instruction
•On drug application suspension
•On drug withdrawal from circulation
•On resumption of drug application
•On termination of verification tests
•On making amendments to VT protocol
Publication of information
on resolutions of the
Ministry of Healthcare
and Social Development of
Russia on the website of
the Federal Service for
Surveillance in Healthcare
Publication of
information letters
on drug safety
problems
Federal Service
for Surveillance in
Healthcare (FSSH)
Medical
Product Quality
Public Control
Division
Medical Product
Efficacy &
Safety Monitoring
Department
Registered drugs
Reports on adverse
effects, severe
adverse effects,
unforeseeable
adverse effects,
particular features of
drug interaction
Regular safety
reports
Drugs in
clinical trials
Reports on severe
unforeseeable
adverse drug
reactions
Annual drug safety
reports
6. Federal Drug Circulation Law dated April 12, 2010, No. 61-FZ
Article 64
Section 3. Pharmaceutical entities shall be obliged to notify of all instances of
side effects not specified in the drug application instructions (leaflet), оf
severe adverse drug reactions, unforeseeable adverse reactions resulting
from application of medicinal drugs, of particular features of drug
interaction with other drugs, which have been found in clinical trials and drug
application, in such manner as established by the competent federal executive
authority.
6
7. Federal Drug Circulation Law dated April 12, 2010, No. 61-FZ
Article 64
Clause 4. For non-disclosure or concealment of the information
envisaged in Part 3 of this Article, the persons who become aware
of such information by the nature of their professional activities
shall be liable according to Russian law.
Article 19.7, Russian Administrative Procedural Code, envisages liability for non-disclosure or delay with disclosure
of information (data) – the penalty for officials of RUB 300-500; for legal entities, RUB 3,000-5,000
Article 32
Cancellation of drug state registration
The resolution to cancel drug state registration is made in the following case:
Section 1. Presentation by FSSN of the opinion on the risk or threat to human health or life posed by drug application,
which surpass its efficacy, based on the results of its drug safety monitoring.
Section 4. Non-presentation by the applicant of the information that may entail the need in making amendments to
documents contained in the registration file for the registered drug within thirty business days from these changes.
8. Periodical Safety Update Reports (PSUR)
PSUR (or) by the drug manufacturer [… ] on electronic or paper media, within
the periods of time calculated from the date when the drug is registered in the
country where it is first permitted for medical application:
• during the first two years from the drug registration: once in 6 months;
• during the subsequent two years, the third and the fourth years from the drug
registration: annually;
• starting from the fifth year from the drug registration: once in three years.
Periodical reports shall be provided within 30 days from the counting period
expiry date.
(order by the Ministry of Health and Social Development of the Russian
Federation dated August 26, 2010, No. 757n)
9. Main Formats of PSUR Submitted to FSSH
• ICHE2C (R1), Clinical Safety Data Management: Periodical Safety Reports for
Drugs Available on the Market (PSUR)
• ICH E2C (R2), Periodical Report on Drug Risk and Benefits Ratio (PBER)
• The format described in the Methodical Recommendations, Guidelines on
Establishing the Drug Safety Monitoring System at Drug Manufacturers or
Registration Certificate Holders, as approved by FSSH’s Head on October 5, 2009
NB! At present, FSSN finishes working on the Methodical Recommendations on
drafting of periodical drug safety reports by developers and manufacturers of
the drugs circulating in the Russian Federation.
10. Changes in Registration of Adverse Reaction Reports in
2009/2013
2009 2010 2011 2012 2013
0
2000
4000
6000
8000
10000
12000
14000
16000
Forecast
Medical care
institutions (Regional
centers)
Pharma companies
Federal Monitoring
Center
Roszdravnadzor (CA)
5,955
10,182
12,646
13,745
14,940
11. Existing Challenges in Collection and Review of
‘Spontaneous’ Adverse Reaction Reports
• Frequency of reporting is lower than in the European Community or U.S.A.
• Pressure on physicians leads to deterioration of the reports or formal
approach to work (reports on minor and foreseeable adverse reactions,
same-type data etc.)
• Incorrect assessment of severity and predictability of the reactions as well
as the causal relationship
• Low quality of the significant number of reports: there is no information on
the patient’s co-morbidities, the treatment mode, the adverse reaction
outcome, and the results of instrumental tests (ideally, the scope of
information should approximate to the hospital discharge summary)
12. Spontaneous Reports: Method Limitations and Problems
• Low reportability (1%-10% of detected reactions in the countries with
the well-developed pharmacovigilance system)
• The number of reports depends on the length of stay on the market,
the mass media focus, and biased attitude of healthcare specialists
• It is impossible to assess the frequency of adverse reactions
• It is impossible to identify the reactions that develop in case of lengthy
application and in the period long after the drug application onset
15. Post-Translation Modification
COOH
Variability in N-linked carbohydrate
side chains
O-Glycosylation
Proteolysis at Arg-X
N-terminal sequence length
variation
NH2
t-PA (Alteplase): a relatively small protein!
Deamidation of Asn residues
Oxidation of Cys or Met
residues
Single-chain and two-chain
forms
1.09 x 109 options are possible!
15
17. –Most of biologicals are capable of inducing the immune response, during which
–The antibodies to the active agent may neutralize the molecule effect
–The cross-response to own biological molecules cannot be eliminated (Schellekens H. Relationship between
biopharmaceutical immunogenicity of epoetin alfa and pure red cell aplasia. Curr Med Res Opin. 2003;19(5):433-4.)
–Clinical trials are mandatory because animal tests cannot predict the immune response in the human
body.
– Besides, it is impossible to predict the risk of neutralizing antibodies in the long-term
–The immunogenicity risk for different indications should be estimated independently and separately
Accessory substances and
impurities
Schellekens H. Nat Rev Drug Discov. 2002;1:457-62.
Immunogenicity
Biological molecule
18. Biological Safety Problems
• Different safety profiles for the original drug and biosimilar
• Possible differences in frequency of C and D type reactions
• Impact of the production process on safety
• Different safety indicators when applied for different indications
• Immunogenicity
• Significant individual variability of effects
19. Safety Monitoring Problems of Biotheraupeutics
•Each biological necessitates de novo post-marketing safety study (the analysis of
reactions under the international non-proprietary name is not permitted)
•But: the originator’s safety problems may be identified for biosimilars, too.
•Separate review of spontaneous reports does not allow
–Detecting reactions that develop in case of long use and in the remote drug application period (C and D
type reactions)
–Detecting the responses that are similar to the main disease symptoms
–Carrying out comparative assessment of the originator and the biosimilar efficacy
–Assessing change in the frequency of adverse reactions is some particular patients in dynamics
In addition, it is difficult to assess how efficient the spontaneous report method is in
identifying ‘production’ problems in long-applied drugs
•A comprehensive biosimilar safety description is possible, if the entire range of
pharmacovigilance methods is used (post-registration surveys, registers, active
monitoring etc.)
•Efficient and safe application of biosimilars necessitates planning of the efforts
aimed at detecting and mitigating the risks of their use at the development stage.
20. Pre-Registration Pre-Clinical and Clinical Trials of
Biosimilars in the European Community
• Pre-clinical trials:
– Comparative nature (identification of possible differences in the safety profile)
– The animal type selection is determined by pharmacological activity of a drug
– Pharmacodynamics study and, at least, one subacute toxicity study
• Clinical trials:
– In certain cases, a comparative pharmacodynamics and pharmacokinetics study
may be sufficient to prove ‘similarity’; however, comparative clinical trials
(normally for the main indication) are often required
– Clinical trials may be conducted using surrogate end points (e.g. dynamics for
demyelinization foci at MRI in multiple sclerosis patients in interferon clinical trials)
– Extrapolation of clinical trial findings to other indications is limited
– Remote immunogenicity study findings (during 1 year) are required for long-
applied drugs
21. European Community Biosimilar Guidelines
biotechnologically obtained proteins
htpp://www.emea.europa.eu/htsm/human/humanguidelines/multidiscipline.htm
Guideline (CHMP/437/04)
“Guideline on Biosimilar Medicinal Products”
Quality
Pre-clinical
Clinical
Insulins
Growth
hormones
Epoetin Interferons
Granulocyte-
macrophage
colony-
stimulating
factor
Funda-
mental
principles
General
require-
ments
Requirements
for certain
drugs
Monoclonal
antibodies (draft)
22. Registration Stage in EC
• Insufficiency of information on immunogenicity and the impact of
antibodies on the drug efficacy
• Lack of data on long-term application
• No data on application for the originator’s other indications
• The need in prompt detection of quality defects
• Intercheangibility problem
23. Biosimilars Risk Management – EC Experience
Risk management – the set of
pharmacovigilance operations and events
aimed at detection, determination, prevention
or mitigation of drug-related risks, including
assessment of the efficiency of these efforts
Objectives
•Post-registration assessment of the risk and
benefits ratio
•Development and implementation of risk
mitigation efforts, with benefits preservation
•Risk mitigation effort efficiency assessment
•Corrective efforts
Drug risk management plan
Part I
•− Safety Specification
•− Pharmacovigilance Plan
Part II
− Evaluation of the Need for Risk Minimization Activities
− Risk Minimization Plan
EMEA Guideline on Risk Management Systems for Medicinal Products
for Human Use (EMEA/CHMP/96268/2005
The risk management plan is part of
the biosimilar registration file
24. Observation Studies
• The possibility of safety assessment in clinical practice
• The studies are planned based on the pre-registration study data and
the originator safety information
• The number of participants depends on the anticipated frequency of
adverse reactions
– If the reaction risk is over 1%, approx. 300 participants may be sufficient to detect
at least one reaction
• To assess differences in frequency of the extremely rare reactions, it
may be necessary to maintain global registers with dozens of
thousands of patients (e.g. to detect a 4-fold increase in frequency of
fractional red-cell aplasia, it was necessary to review 20,000 patient
years of drug application, PRIMS register)
27. • Drug information dissemination
• Application instructions
• Specialized educational programs
• Audio and visual information
• Drug guidelines for physicians pharmacists and patients (Patient Info
booklets)
• II. Drug application control
• Drug prescription status determination
• Designation of the persons entitled to prescribe/ dispense drugs
• Prescription/ dispensing control
• Control over the maximum quantity dispensed per prescription, limitation
on the prescription validity period (observation frequency increase)
• Patients’ informed consent (in some countries, it is applied with respect to
registered drugs)
• Maintenance of patient registers
• Cards of drug recipients
Risk Prevention Efforts
28. Amendments to the Federal Drug Circulation Law
•Harmonization of basic pharmacovigilance definitions with ICH documents;
•An option for expert companies to take part in drug safety monitoring;
•Liability of registration certificate holders for drug safety:
–Possibility to establish legal monitoring system requirements in the companies – holders
of registration certificates and sponsors of clinical trials;
–Duties to study the detected safety problems;
–Duties to reduce and prevent risks related to new safety (risk management) problems.
•Possibility to suspend application of a drug or to hold a clinical trial, if legal
pharmacovigilance requirements are not complied with.
29. Future Ways to Improve the Drug Safety Monitoring System
• Increased attention of registration applicants and drug developers to
pharmacovigilance
– Improvement of law and law enforcement practice in indemnification against
damage to life and health and emotional distress (ensuring “investment appeal”
of establishing corporate pharmacovigilance systems)
– Inclusion of requirements to provision of information on safety tools for certain
drug groups into the registration file (by analogy with the risk management plan
in EC)
– Introduction of special conditions of the permit to use certain drug classes with
a high safety risk profile in the post-registration period (statutory post-
registration intervention or observation studies, active monitoring, information
support to physicians and consumers etc.)
30. • Promotion of the drug safety monitoring system development at
pharmaceutical enterprises
– Development of the national standard on establishing the corporate
pharmacovigilance system – drug registration applicants (the requirements to
responsible persons, adverse reaction information collection, processing and
systematization system, standard operating procedures)
– Drawing attention to the problem of proper and reasonable drug use (requirements
to comprehensible presentment of information in the instruction, enabling to
disseminate patient-oriented flyers, recommendations on approaches to providing
important information on drug safety and relations with physicians)
– Establishment of the uniform schedule for filing periodical statements on generic
drugs (enabling generic manufacturers with one international non-proprietary name
to draft one joint report)
– Improvement of the electronic drug safety information processing and collection
systems - to ensure transition to the electronic receipt of PDSR and spontaneous
reports, development of adverse reaction information statistical analysis tools
Future Ways to Improve the Drug Safety Monitoring System
31. • Ensuring sufficient personnel potential of business units of healthcare
management bodies, regional centers and treatment institutions involved in
drug safety monitoring
• Development of WHO-recommended network tools for the drug safety
monitoring. Legal establishment to the status of regional monitoring centers as
expert organizations that promote adverse reaction detection, improvement of
the quality of information on them as provided to FSSH, advice to physicians on
drug safety problems
• Development of relations with WHO on early detection of drug safety problems,
improvement of pharmacovigilance information support and professional
training. Use of international data arrays on adverse reactions tо detect safety
alarms (VigiBase)
• Development of scientific and practical cooperation with foreign regulatory
authorities (including ЕМА), in particular, discussion of the opportunities to gain
access to spontaneous report bases (Eudravigilance)
Future Ways to Improve the Drug Safety Monitoring System
32. Thank you!
FEDERAL SERVICE FOR SURVEILLANCE IN HEALTHCARE
Medical Product Quality Public Control Division
Medical Product Efficacy & Safety Monitoring Department
4, Bldg 1, Slavyanskaya Square, Moscow 109074
Tel. (499)578-02-73
Facsimile: (495)698-17-73
Email: pharm@roszdravnadzor.ru