ISSN 2321–3647
Sun, 19 Nov 2017

Generic Drug Registration Procedure in US and European Markets

Pasumarthy. N. V. Gopal2, Mamillapalli V Ramana*1, M. V. Nagabhushanam1, D. Nagarjuna Reddy1

1. Department of Pharmaceutical Management and Regulatory Affairs, Hindu College of Pharmacy, Guntur, India-522002.

2. Department of Pharmaceutical Biotechnology, Hindu College of Pharmacy, Guntur, A. P, India-522002.


This topic aims at reviewing the drug filing and different aspects of obtaining United States Food & Drug Administration (USFDA) and European Medicines Agency (EMA) approval for a drug in order to get a Marketing Authorization in US &Europe and their effective role in improving the standards laid down by them. The goal of the approval process is to provide enough information about the drug safety and efficacy in human beings. ANDA is a regulatory submission for authorization of generic version of New Drugs after expiry of its patent period in US. Marketing authorization application is filed with the relevant authority in the Europe (typically, the UK's MHRA or the EMA’s Committee for Medicinal Products for Human use (CHMP)) to market a drug or medicine. In Europe there are four types of marketing authorization procedures like national procedure (NP), centralized procedure (CP), decentralized procedure (DCP) and mutual recognition procedure (MRP) for getting generic drug approval process. The Common Technical Document (CTD) is a set of specification for application dossier, for the registration of Medicines and designed to be used across Europe, and the United States. Quality, Safety and Efficacy information is assembled in a common format through CTD.

Keywords: Generic drugs, drug approval process, ANDA, MAA, CTD format.

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