Abstract

A REVIEW ON GENERIC DRUGS REGISTRATION PROCEDURE IN USA & CANADA

M. V. S. Kavitha*, G. Indu, M. V. Nagabhushnam, Brahmaiah Bonthagara, D. Nagarjuna Reddy

Abstract

This study aims to compare the generic drug approval and registration processes in the regulatory markets of USA and Canada. Based on the information collected from various sources such as regulatory agencies sites, Government websites, discussion with regulatory agents, interviewing pharma professionals and literature survey from various journals, a clear picture on the generic drug approval and registration process of each country was drawn. Different regulatory authorities viz., Food and Drug Administration (FDA) of USA and Health Canada carried out the generic drug approval and registration process in the respective countries. After analysing the various requirements for the generic drug approval in the above stated countries, it was concluded that the regulatory guidelines of Europe and Brazil was not well defined. But FDA gives very much well defined requirements.

Keywords: Generic drugs, USA, Canada.