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Regulatory Filing of Generic Drugs in Europe
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| Author:
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SOORIA S, RAJU KAMARAJ, SONIA KARUPPAIAH
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| Abstract:
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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.
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| Keyword:
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Generic, European Medical Agency, Marketing Authorization Application, Regulatory authority
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| EOI:
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-
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| DOI:
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https://doi.org/10.31838/ijpr/2021.13.02.351
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| Download:
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Request For Article
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