Abstract

PHARMACEUTICAL REGULATORY AFFAIRS AND IT’S FUTURE ASPECTS - REVIEW

Ishte Ashwini* and Kamble Aarti

ABSTRACT

The pharmaceutical is a regulated industry throughout all over countries in the world. Regulatory agencies and organisations play an important responsibility towards need of legal procedures related to drug development process in a country. In every country follow their own regulatory rules, regulations and issue the guidelines to regulate the drug development, licencing, registration and marketing. Graduate students of scientific background can choose regulatory affair as career option who enjoy teamwork in pharmaceutical world. Drug regulatory contain both scientific and legal aspects of drug design and development.

Keywords: Regulatory affairs, History of regulatory affairs, World regulatory bodies, Approval process, Role and responsibilities of regulatory affairs and company, future aspects.