Drug Regulatory Agencies.

its about the regulatory agencies all over the world

1. DRUG REGULATORY AGENCIES IN DIFFERENT CONTRIES PREPARED BY: PRIYANKA CHAKOTE.

2. Meaning Introduction Key function Agencies in INDIA Agencies in US Agencies in JAPAN Agencies in EU ICH References CONTENT

3. Drug “ All medicines for internal or external use of human beings or animals and all substances intended to be used for diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals .” Regulation “To regulate means to control something so that it functions properly ”. MEANING OF DRUG REGULATION

4. 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 . INTRODUCTION

5. 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 . KEY FUNCTION OF THE DRUG REGULATORY AGENCY

6. DRUG REGULATORY SYSTEAM IN INDIA MAIN BODIES: 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)

7. CDSCO-Geographical location of Zonal Offices.

8. DRUG CONTROLLER GENERAL

9. 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. FUCTIONS UNDERTAKEN BY CDSCO

10. 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). DRUG REGULATORY AGENCIES IN US

11. 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. MISSION

12. 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. RESPONSIBILITIES OF FDA

13. DRUG REGULATORY AGENCY IN JAPAN MAIN BODIES: Ministry of Health and Welfare National Institute of Infectious Diseases National Institute of Health Sciences

14. HISTORY In January 1938, the Ministry of Health and Welfare was established by integrating the administrations of the Sanitary Bureau and the Social Affairs Bureau in the Ministry of Home Affairs. In September 1947 The Ministry of Labour was established by integrating labour administrations that had previously been conducted by the Ministry of Health and Welfare.

15. 17 MHLW Social 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

16. 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. FUNCTIONS OF MHLW

17. 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

18. DRUG REGULATORY AGENCIES IN EU MAIN BODIES: EU Legislation - Eudralex European Directorate for the Quality of Medicines and Healthcare (EDQM) European Medicines Agency (EMEA) Heads of Medicines Agencies (HMA)

19. European Directorate For The Quality Of Medicines & Health Care 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.

20. 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. MISSION

21. 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 EMA

22. 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 ACTIVITES OF EMA