Comparative Study of New Drug Application Procedure in US, EU and India

Abstract

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. All new / generic drug products must be approved by the respective regulatory agency governing the respective market before a particular product can be introduced into the market. By law, all new drugs must first be shown to be safe and effective before they can be approved by the respective regulatory agency for marketing. USFDA is the regulatory agency which is responsible for safety regulation of the food and drug products in US. EMA is the regulatory agency decentralized body which is responsible for safety regulation of the food and drug products in Europe. Drug approval process in USFDA involves submitting of an Investigational New Drug Application, followed by submission of New Drug Application. The applications are reviewed and agency officials examine the drug’s safety and efficacy data and the drug is approved. EU establishes 4 different drug approval processes: 1) Centralized Procedure 2) Decentralized Procedure 3) National Procedure 4) Mutual Recognition Procedure.