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.
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