Abstract

IMPLICATIONS OF REGULATORY AFFAIRS IN PHARMACEUTICAL INDUSTRY

S. Sivaprasad*, P. V. Murali Krishna, CH. Sadakvali, Kalyani Peluri and K. V. Umamaheswari

ABSTRACT

Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory Affairs also has a very specific meaning within the healthcare industries (pharmaceuticals, medical devices, Biologics and functional foods). This department is responsible for knowing the regulatory requirements for getting new Products approved. They know what commitments the company has made to the regulatory agencies where the product has been approved. They also submit annual reports and supplements to the agencies. The Regulatory Affairs professional‟s job is to keep track of the ever changing legislation in all the regions in which the company wishes to distribute its products. They also advise on the legal and scientific restraints and requirements, and collect, collate, and evaluate the scientific data that their research and development colleagues are generating. They are responsible for the presentation of registration documents to regulatory agencies, and carry out all the subsequent negotiations necessary to obtain and maintain marketing authorization for the products concerned. They give strategic and technical advice at the highest level in their companies, right from the beginning of the development of a product, making an important contribution both commercially and scientifically to the success of a development program and the company as a whole.

Keywords: CDSCO, NPPA, IND, ANDA.