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WJPR

World Journal of Pharmaceutical Research

( An ISO 9001:2015 Certified International Journal )

An International Peer Reviewed Journal for Pharmaceutical and Medical Research and Technology

Impact Factor : 8.084

ICV : 90.8

WJPR Citation

	All	Since 2011
Citation	2903	2393
h-index	27	24
i10-index	68	60

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Best Paper Awards

World Journal of Pharmaceutical Research (WJPR) will give best paper award in every issue in the form of money along with certificate to promote research activity of scholar.

Best Paper Award :
Dr. Muhammad Baqir MR Fakhrildin
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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.

[Full Text Article]