Abstract

DOSSIER SUBMISSION PROCESS IN EUROPE AND UNITED STATES

Dnyaneshwar Mali* and Dr. S.V. Desphande

ABSTRACT

Current oblige of Regulatory Affairs reveals diverse countries need to follow different regulatory requirements for marketing authorization Application (MAA) approval of new drugs. In this present effort, study expresses the drug approval process and regulatory requirements according to US Food and Drug Administration (USFDA), European Medical Agency (EMA). Generic drugs in EU are endorsed under the Marketing Authorization Application. Medicinal products are highly monitored 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. USFDA is one the most regulated agencies wherein the submission process is hairsplitting. A Generic Product must satisfy the guidelines built up by FDA in RLD (Reference listed drug).

Keywords: Generic drugs, Marketting approval, European Medical Agency.