INTRODUCTION

Medicines have their existence in parallel with the existence of mankind. It is perhaps

as old as a human being. The current pharmaceutical industry is more systematic,

well organised and in compliance with respective guidelines. This is because of effective

pre- and post-approval regulation of new drugs and the existing drugs. Regulatory

affairs play this role for pharmaceutical manufacturing companies and the government

of the country. It is a new profession which emerges after government and

manufacturing companies felt the need for a bridge in them which promotes

coordination and communication. The regulatory affairs act as an interface between

government and manufacturing companies.

Regulatory affairs is actively involved in every stage of drug development in case

of new drug and post-approval surveillance in case of an existing drug. All the

applications for getting a pharmaceutical product approved for entering into the market

has been prepared by the regulatory department of companies. The regulatory

professionals act as liaison with government regulatory agencies. These applications

are reviewed by government regulatory agencies to check the compliance with issued

guidelines. The regulatory department of the company internally also liaison with

QC, marketing, production, administration and other departments of company to keep

them updated with changes in guidelines and to ensure their compliance with the

guidelines.

HISTORICAL OVERVIEW OF REGULATORY AFFAIRS

The quality assurance and regulation of medicines evolved gradually over time. Many

unfortunate incidents have catalysed the development of regulations and guidelines

of assuring quality, safety and efficacy of medicines. In 1947, in United States over

100 died due to sulphanilamide elixir. This event led to the introduction of Federal

Food and Cosmetics Act for new drugs in 1948. In 1956, the introduction of Thalidomide

(a drug prescribed to pregnant women for morning sickness) in 46 different countries

resulted in an estimated 10000 babies born with phocomelia (Deformities related to

limbs). This event results in reshaping of the whole regulatory system. Due to these

types of incidents at different stage regulatory bodies introduce new laws and

guidelines which make norms related to drug approval or site approval stricter than

before. Due to more guidelines and laws, the need for regulatory affairs has been felt.

It led to the emergence of regulatory affairs as a profession.