Registration of Drug Product dossier application as per EU Guidelines

Abstract

Due to variations in the regulatory norms of registration dossier in different countries, there is a strong need for harmonization by ICH for approval of drugs. Generic drugs in EU are approved under the Marketing Authorization Application. Bioavailability and Bioequivalence study data is critical in the generic drug approval process. Moreover, there are several approaches to assess BA/BE, each regulatory authority has put forth its own regulations/guidances for conducting BA/BE studies. Medicinal products are highly regulated in the European Union (EU) and are subject to a separate, complicated system of approvals that governs how, when, where, and in what form such products will be allowed to be sold within the borders of EU. The present marketing authorization procedures applicable to European Economic Area included 27 EU member states and the three EEA European Free Trade Association states (Iceland, Liechtenstein and Norway). Marketing Authorization Application is applied based on National procedure, mutual recognition procedure, centralized and decentralized procedure. Hence procedure for Registration of Drug Products was discussed in detail in this current review.