Abstract

ROLE OF DRUG REGULATORY AFFAIRS IN PHARMA INDUSTRY

Aparna Nigal, Avinash Darekar* and Ravindra Saudagar

ABSTRACT

Drug Regulatory Affairs (DRA) is a vital unit in a pharmaceutical company as it is concern about the healthcare of people and shelf life of product. it provide planned, premeditated and prepared direction and support for working within regulations to expedite the development and delivery of safety and efficacy in pharmaceuticals. Regulatory affairs (RA) professionals are engaged in pharmaceutical industry, government, academic research and clinical institution. The responsibility of regulatory affairs is to develop and perform a regulatory strategy to ensure that the collective efforts of the drug development team results in a product that is approvable by universal regulators but is also differentiated from the competition in some way and also is to ensure that the company‗s actions from non-clinical research through to advertising and promotion, are conducted in accordance with the regulations and guidelines established by regulatory authorities. The Regulatory Affairs department is a vital part of the organizational structure of pharmaceutical companies. It acts as a bond between inter phase of drug development, manufacturing, marketing and clinical research and as a bridge between the company and the regulatory authorities. As India is rising very rapidly in pharmaceutical area, there is a need of regulatory affairs professionals to setup the current needs of industries for the global struggle. Today 35 member countries along with 11 contender countries and 4 international agencies have connected together to generate the Pharmaceutical Inspection Cooperation Scheme (PIC/S) to advance a globally established GMP.

Keywords: Drug regulatory affairs, Regulatory agencies, FDA, Pharmaceutical Inspection Cooperation Scheme (PIC/S), GMP.