Abstract

COMPARATIVE STUDIES FOR FILING AND MARKETING AUTHORIZATION OF GENERICS IN EUROPE, UNITED STATES & INDIA

G. Ramakrishna*, M. Bhavya Shalini, Brahmaiah Bonthagarala, M. V. Nagabhushanam and Y. Ratna Sindhu

ABSTRACT

The main aim of the topic to review and compare the generic drug filing process and different aspects of approval between United States Food and Drug Administration (USFDA), European Medical Agency (EMA), and DCGI Drug Controller General Of India approval„s for Marketing Authorization of a drug in US & Europe and India, and their role in improving the standard laid down by them. The goal of the approval process is to provide enough information about the drug which should show safety and efficacy in human beings. ANDA is a regulatory submission for marketing authorization of generic version of drugs in United States. Marketing authorization application (MAA) is the relevant regulatory submission procedure to be followed in the Europe to market a drug. In India Marketing authorization application for generic drugs is the regulatory submission procedure laid down by Drug Controller General of India (DCGI). The Common Technical Document is a common format. A set of specifications for application dossier, for registration of medicines and designed to be used across Europe, United State and India. Quality, Safety and Efficacy information is assembled in a common format through CTD.

Keywords: USFDA, API, DCGI, MAA, EMEA.