M. V. Nagabhushanam

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.

In this study work a comparative and differentiation has been put forwarded to make some recommendations of the regulatory framework. Now a day’s it’s too hard to invent a new drug so, the major pharmaceutical companies mainly depend up on the generic production of drugs. The generic drugs are very cheap when compared to innovator drugs in production cost and these generic products are customer friendly. . In this study the information was extracted from certain journals, text books, and related websites and from the authorized regulated authorities of the particular countries. The Topics covered in this study are introduction to regulatory affairs as well as regulated authorities in USA, CANADA and EUROPEAN UNION. About the data exclusivity and patent protection term information and the comparison among USA, CANADA and EUROPEAN UNION are enlisted in this topic. The comparison between the number of NDA approvals and ANDA approvals of USA, CANADA and European Union are represented statistically from 2006 to 2013 are labeled. The number of total molecule wise approvals in these countries is represented through pie charts and the top most pharmaceutical firms and their brand names of inhalation and nasal products are mentioned.