Drug Regulatory Agencies.
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Transcript of Drug Regulatory Agencies.
PREPARED BY:
PRIYANKA CHAKOTE.
Meaning Introduction Key function Agencies in INDIA Agencies in US Agencies in JAPAN Agencies in EU ICH References
Drug“All medicines for internal or external use of
human beings or animals and all substancesintended to be used for diagnosis, treatment,mitigation or prevention of any disease ordisorder in human beings or animals.”
Regulation“To regulate means to control something
so that it functions properly”.
Drugs play important role in the health and economy of a country.
Pharmaceutical drugs are available from number of source.
To ensure that that they meet prescribed standards. To ensure the safety, efficacy and quality of drugs as well
as accuracy and appropriateness of the drug information available to the public.
Product registration.
Regulation of drug manufacturing, importation , and distribution.
Adverse drug reaction monitoring.
Licensing of premises & persons & practices.
Main goal of the agency is to guarantee the safety , efficacy, and quality of the available drug product .
DRUG
REGULATION
QUALITY CONTROL
DRUGS LAWS .
DRUG REGULATORY
BOARDS
DRUG REGULATORY
AGENCY
DRUG
INFORMATION
CENTER
Central Drug Standard Control Organization (CDSCO) Ministry Of Health & Family Welfare (MHFW) Indian Council Of Medical Research (ICMR) Indian Pharmaceutical Association (IPA) Drug Technical Advisory Board (DTAB) Central Drug Testing Laboratory (CDTL) Indian Pharmacopoeia Commission (IPC) National Pharmaceutical Pricing Authority (NPPA)
To approve license to the various manufacturing of certain categories of drug as central licensing approving authorities i.e. For Blood Banks, Large Volume Parental And Vaccines And Sera.
To regulate the standards of the imported drug products.
Work Relating To The Drug Technical Advisory Board (DTAB) And Drugs Consultative Committee.
Testing Of Drugs By Central Drugs Lab.
Publication Of The Indian Pharmacopeia.
MAIN BODIES
The Food And Drug Administration (FDA).
National Institute Of Health (NIH).
Centers For Disease Control And Prevention .
Department Of Health And Human Service (DHHS).
Fed World Us Information .
National Center For Complementary And Alternative Medicine (NCCAM).
The Food and Drug Modernization Act states that the FDA has 4 roles:
To promote health by reviewing research and approving new products.
To ensure foods and drugs are safe and properly labeled.
To work with other nations to “reduce the burden of regulation”.
To cooperate with scientific experts and consumers to effectively carry out these obligations.
FDA
The Office of the
Commissioner
(OC)
The Center for Drug Evaluation
and Research
(CDER)
The Center for Biologics
Evaluation and Research
(CBER)
The Center for Food Safety and
Applied Nutrition
(CFSAN)
The Center for Devices and Radiological
Health (CDRH)
The Center for
Veterinary Medicine (CVM)
The National Center for Toxological
Research (NCTR)
The Office of Regulatory
Affairs (ORA)
Center for tobacco product
Protecting the public health by Assuring that the food products are safe.
Assuring human and veterinary drugs, and vaccines and other biological products and medical devices intended for human use are safe and effective.
Protecting the public from electronic product radiation. Assuring cosmetics and dietary supplements are safe and
properly labeled. Advancing the public health by helping to speed product
innovations. Helping the public get the accurate science-based
information they need to use medicines, devices, and foods to improve their health.
MAIN BODIES:
Ministry of Health and Welfare National Institute of Infectious Diseases National Institute of Health Sciences
In January 1938, the Ministry of Health and Welfarewas established by integrating the administrations of theSanitary Bureau and the Social Affairs Bureau in theMinistry of Home Affairs.
In September 1947 The Ministry of Labour wasestablished by integrating labour administrations thathad previously been conducted by the Ministry of Healthand Welfare.
17
MHLWSocial insurance
agency
Ministry proper
Minister’s secretariat
Heath policy bureau
Heath service bureau
PFSB
Social welfare & war victim’s relief
bureau
Health and welfare bureau for elderly
Equal employment children & family
bureau
Insurance bureau
Pension bureau
Director general for policy planning
Social insurance agency
Ministry proper
PFSB
Social welfare & war victim’s relief
bureau
Health and welfare bureau for elderly
Equal employment children & family
bureau
Insurance bureau
Pension bureau
Director general for policy planning
Social Welfare :
Services for elderly people Services for persons with disabilities
Social Security :
Pension systems that will ensure income in elderly age Long term insurance to provide nursing care services Public assistance systems that guarantee minimum standards.
Public Hygiene :
Appropriate medical services for diseases & injuries
Ensuring the safety of food, Water and medical supplies
Research into health science in order to make technological advances
Maternal and child health
Job Security :
Promotion of employment
Employment of elderly people
Employment of persons with disabilities
Management of the employment insurance system
MAIN BODIES:
EU Legislation - Eudralex
European Directorate for the Quality of Medicines and Healthcare (EDQM)
European Medicines Agency (EMEA)
Heads of Medicines Agencies (HMA)
The EDQM (Council of Europe) is a key European Organisation involved in Harmonisation & Co-ordination of Standardisation, Regulation & Quality Control of Medicines, Blood Transfusion, Organ Transplantation, Pharmaceuticals and Pharmaceutical Care.
In 1996 The European Directorate for the Quality of Medicines (EDQM) is created.
To contribute to the basic human right of access to good quality medicines and healthcare and to promote and protect human and animal health by:
Establishing and providing official standards which apply to the manufacture and quality control of medicines in all signatory States of the "Convention on the Elaboration of a European Pharmacopoeia" and beyond;
Ensuring the application of these official standards to substances used in the production of medicines.
EMA is a European agency for the evaluation of medicinal product.
EMA was set up in 1995.
From 1995 to 2004, EMA was known as European agency for the evaluation of medicinal product.
The European Medicines Agency (EMA) is a decentralized body of the European Union, located in London
Mission: to foster scientific excellence in evaluation and supervision of medicines
Provides independent, science-based recommendations on the quality, safety and efficacy of medicines.
Applies efficient and transparent evaluation procedures to help bring new medicines to the market.
Implements measures for continuously supervising the quality, safety and efficacy of authorised medicines.
Provides scientific advice to stimulate the development and improve the availability of innovative new medicines