This document provides an overview of drug regulatory affairs. It defines regulatory affairs as the profession that acts as the interface between pharmaceutical industries and drug regulatory authorities. The goal of regulatory affairs professionals is to protect human health by ensuring safety, efficacy and quality of drugs and ensuring accurate product information. It discusses why regulatory affairs is needed, highlighting past drug tragedies that led to increased regulation. Regulatory affairs helps reduce development failures and provides assistance on issues like licensing, registration, development, manufacturing and quality guidance.

1. NAGA CHANDRIKA PALLAM, M.PHARM
ASSIST.PROFESSOR
Geethanjali College of Pharmacy, Hyd.
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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.
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3. Regulatory affair is a profession which acts as the interface between
pharmaceutical industries and Drug Regulatory Authorities
(Government authorities) around the world.
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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.
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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
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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
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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
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10. Why Drug regulatory affairs?
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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
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12. THANK YOU
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