The role and remit of regulatory authorities and FDA

Role and remit of regulatory authority and Food and Drug Administration

1. THE ROLE AND REMIT OF REGULATORY AUTHORITIES AND FDA DONEBY A.SHEIK ABDULLA (117012101307) M.SORNAMALYA (117011101310) M.THASLEEMA PARVEEN(117011101310) DRUG DISCOVERY AND DEVELOPMENT 10-03-2020 1 Course Teacher : P. MALA Assistant professor Department of Biotechnology PMIST

2. THE ROLE AND REMIT OF REGULATORY AUTHORITIES Regulatory authorities are independent governmental body established by legislative act in order to set standards . In a specific field of activity, or operations ,in the private sector of the economy to enforce those standards. Regulatory agencies became popular means of promoting fair trade and consumer protection as problems of commerce and trade became complex , particularly in 20 th century. The idea of the regulatory agency was first advanced in the united states DRUG DISCOVERY AND DEVELOPMENT 10-03-2020 2

3. DRUG REGULATORY AUTHORITY The drug regulatory authorities(DRA) is the agency that develops and implements most of the legislation and regulation on pharmaceuticals. Its main task is to ensure the quality , efficacy and safety of the drugs, and the accuracy of the product information . This is done by making certain rules that the manufacture, procurement, import, export, distribution, supply and sale of drugs, product promotion and advertising, and clinical trials are carried out according to specified standards. DRUG DISCOVERY AND DEVELOPMENT 10-03-2020 3

4. Functions of regulatory authority Product registration (drug evaluation and authorization, and monitoring of drug efficacy and safety) Regulation of drug manufacturing, importation, and distribution Regulation & Control of drug promotion and information. Adverse drug reaction (ADR) monitoring. Licensing of premises, persons and practices. Main goal of drug regulation is to guarantee the safety, efficacy and quality of drugs available to public. DRUG DISCOVERY AND DEVELOPMENT 10-03-2020 4

5. It is governed by both Centre and State Governments under the Drugs & Cosmetics Act, 1940. MAIN BODIES: Ministry Of Health & Family Welfare ( MHFW ) Central Drug Standard Control Organization( CDSCO ) Indian Pharmacopoeia Commission ( IPC ) National Pharmaceutical Pricing Authority ( NPPA ) DRUG DISCOVERY AND DEVELOPMENT 10-03-2020 5

6. FDA The FDA represents the American regulatory authority. Its mission statement defines its goal simply as being to “protect public health ” The FDA was found in 1930. The Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services. DRUG DISCOVERY AND DEVELOPMENT 10-03-2020 6

7. It is responsible for regulating and supervising the safety of foods, dietary supplements, drugs, vaccines, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics. The FDA has its headquarters at White Oak, Maryland . The agency also has 223 field offices and 13 laboratories located throughout the 50 states, the United States Virgin Islands, and Puerto Rico. DRUG DISCOVERY AND DEVELOPMENT 10-03-2020 7

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9. FDA- Organizations 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 Toxicological Research ( NCTR ) The Office of Regulatory Affairs ( ORA ) DRUG DISCOVERY AND DEVELOPMENT 10-03-2020 9

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11. FDA CENTERS DRUG DISCOVERY AND DEVELOPMENT 10-03-2020 11

12. Responsibilities of US-FDA FDA is responsible for protecting the public health by assuring the safety Efficacy and Security of human and veterinary drugs Biological products Medical devices Us nation’s food supply Cosmetics and Products that emit radiation By helping to speed innovations that make medicines more Safer and More affordable Effective DRUG DISCOVERY AND DEVELOPMENT 10-03-2020 12

13. By helping the public get the Accurate Science-based information they need to use medicines & Foods to maintain and improve their health. DRUG DISCOVERY AND DEVELOPMENT 10-03-2020 13

14. Functions of US-FDA 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. DRUG DISCOVERY AND DEVELOPMENT 10-03-2020 14

15. US-FDA Regulates Foods, except for most meat and poultry products, which are regulated by the U.S. Department of Agriculture. Food additives Infant formulas ,Dietary supplements Human drugs Vaccines, blood products, and other biologics Medical devices, from simple items like tongue depressors, to complex technologies such as heart pacemakers. Electronic products that give off radiation, such as microwave ovens and X ray equipment. Cosmetics. Feed, drugs, and devices used in pets, farm animals, and other animals. Tobacco products. DRUG DISCOVERY AND DEVELOPMENT 10-03-2020 15

16. US-FDA Doesn't regulates Advertising (except for prescription drugs, medical devices, and tobacco products). Alcoholic beverages Some consumer products, such as paint, child-resistant packages, baby toys, and household appliances (except for those that give off radiation) Illegal drugs of abuse , such as heroin and marijuana. Health insurance. Meat and poultry (except for game meats, such as venison, ostrich, and snake). Restaurants and grocery stores. DRUG DISCOVERY AND DEVELOPMENT 10-03-2020 16

17. References: Biopharmaceuticals - GARY WALSH COURTESY – Google images FDA( https://fda.maharashtra.gov.in/Aboutus.aspx ) NPPA ( http://www.nppaindia.nic.in/ ) DRUG DISCOVERY AND DEVELOPMENT 10-03-2020 17

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