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INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH

A Step Towards Excellence
Published by : Advanced Scientific Research
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0975-2366
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IJPR 9[3] July - September 2017 Special Issue

July - September 9[3] 2017

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Regulatory Filing of Generic Drugs in Europe

Author: SOORIA S, RAJU KAMARAJ, SONIA KARUPPAIAH
Abstract: This topic illustrates about generic drug approval process and its challenges faced during filing of generic drugs in Europe. Each country has their own drug approval process companies who are manufacturing the drugs should strictly follow the guidelines given by the country. The approval process in Europe is bit complicated because it contains four steps of approval process. Generic drugs are filled through European Medical Agency and it is approved under Marketing Authorization Application. Regulatory authorities should ensure that drugs are manufactured according to the regulatory guidelines given by European Medical Agency which includes safety, quality and efficacy.
Keyword: Generic, European Medical Agency, Marketing Authorization Application, Regulatory authority
DOI: https://doi.org/10.31838/ijpr/2021.13.02.351
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