Abstract

ROLE OF REGULATORY AFFAIRS IN THE BRICS COUNTRIES

Dakme Papi, Biplab Kr. Dey and Ruhul Amin*

ABSTRACT

BRICS essentially incorporate the developing markets of India, Russia, Brazil, China, and South Africa. The development of the pharmaceutical market in these nations has been expanding the most recent two decades. The growth of the pharmaceutical market relies on the medication administrative framework and administrative medication laws. In the pharmaceutical industry, regulatory affairs play an essential role as the pharmaceutical sector is increasing very rapidly. An organizational undertaking is a calling that goes about as the interface between pharmaceutical business and government specialists over the World. The drive behind the present examination is to analyze existing ERA methodology for human pharmaceuticals and to feature their qualities and limitations. Existing ERA frameworks for human medicines have assumed critical jobs in improving ecological attention to the pharmaceutical businesses and in ensuring natural well being. This article summarizes the various aspect of regulatory affairs in BRICS country and it also gives an insight into the new drug development process and a regulatory guideline of entry of new molecule in BRICS country.

Keywords: BRICS country, Generic drug registration, Medical devices, Regulation.