Regulatory affairs

Regulatory affairs, introduction, History, DRA

1. NAGA CHANDRIKA PALLAM, M.PHARM ASSIST.PROFESSOR Geethanjali College of Pharmacy , Hyd. 1 DRUG REGULATORY AFFAIRS INDUSTRIAL PHARMACY- II B.PHARM IV YEARS IST SEM

2. LEARNING OBJECTIVES To gain the essential knowledge and skills required to help companies to work in regulatory environment. Acquire the foundation to work within or in variety of areas including medical products development, pharmaceutical formulations, sales, strategic marketing and clinical investigations. To know about regulatory process in drug development, formulations, API. To sharpen the understanding of laws that governs the development manufacturing, and commercializing along with the distribution of drugs, biologics and medical devices . 2

3. Regulatory affair is a profession which acts as the interface between pharmaceutical industries and Drug Regulatory Authorities (Government authorities) around the world. 3 PHARMACEUTICAL INDUSTRIES DRUG REGULATORY AUTHORITIES

4. Goal of regulatory affairs professional is protection of human health, ensuring safety, efficacy, and quality of drugs, ensuring accuracy of product information. 4

5. NEED? The need of regulatory affairs of pharmaceutical was felt back in 1950 due to multiple tragedies i.e. sulfanilamide elixir, vaccine tragedy and thalidomide tragedy etc 5 Harold Cole warkins

6. Seventy one adults and 34 children died in the fall of 1937 after taking a drug called Elixir sulfanilamide to treat a variety of ailments, from gonorrhea to sore throat. At that time, no formal government approval required to market new drugs. The disaster provoked a public out cry that led to the passage of the 1938 food drug and cosmetics acts, which gave FDA power to monitor the safety of new drugs 6

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8. 8 ROLE OF DRA What DRA actually do

9. MAJOR REGULATORY AUTHORITIES INDIA - Central Drug Standard Control Organization. Drug controller general of India US --- Food and Drug Administration USFDA. UK ---- Medicines and Health care products regulatory Agency (MHRA) AUSTRALIA ---Therapeutic Goods Administration (TGA) JAPAN ---- Japanese Ministry of health, Labor and welfare (MHLW) EUROPE --- European Directorate for quality of Medicines (EDQM), European Medicines Evaluations 9

10. Why Drug regulatory affairs? 10 Drug development and in order to develop the most efficient and safe pharmaceutical products. The path of the drug registration is laid down with good intended but can be complicated. Somebody who gather all relevant information in one umbrella to bring product in the market for sell. Helps to reduce number of development failures

11. On what issue DRA department provide assistance Licensing Registration Development Manufacturing Quality guidance Pricing Marketing GMP GLP GCP Patent Copyright Trademark Pharma-covigilance 11

12. THANK YOU 12