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
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.
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