REVIEW ON: PHARMACEUTICAL DRUG REGULATORY AFFAIRS & REGULATORY REQUIREMENT FOR DRUG'S APPROVAL IN INDIA, US & EUROPE MARKET

A Drug regulatory approval process, by which a person/organization/sponsor/innovator gets authorization to launch a drug in the market, is known as drug approval process. Drug Regulatory affairs (DRA) is   a   dynamic, rewarding   field   that includes both scientific and legal aspects of drug development. DRA department involved in critical roles in a pharmaceutical industry because it is concern about the healthcare product lifecycle, provide strategic, tactical and operational direction and support for working within regulations to expedite the development and delivery of safe and effective healthcare products to individuals around the world. All Countries have their own regulatory authority, which play role in for enforcing the rules and regulations and issue the guidelines to regulate drug development process, licensing, registration, manufacturing, marketing, labeling and the product life cycle of pharmaceutical products. The approval time in all the countries is almost the same 12 to 18 months with their different approval charges. In this article we focus on the Drug Regulatory affairs, drug approval process and regulatory requirements according to Central Drug Standard Control Organization (CDSCO), US Food & Drug Administration (USFDA), and EMEA, CHMP & NATIONAL HEALTH AGENCY.