A New Drug Approval Process in Europe: A Review

  • Krishnasis Chakraborty
DOI https://doi.org/10.22270/ijdra.v7i3.332

Abstract

Current constrain of Regulatory Affairs reveals diverse countries need to follow different regulatory requirements for Marketing Authorization Application (MAA) approval of new drugs. In this present exertion, study expresses the drug approval process and Regulatory requirements according to European Medical Agency (EMA) (1).

Keywords: Drug Approval, Regulatory Requirements, EMA, Marketing Authorization Application (MAA), CHMP, CMS, RMS

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References

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How to Cite
1.
Chakraborty K. A New Drug Approval Process in Europe: A Review. Int J Drug Reg Affairs [Internet]. 2019Sep.15 [cited 2025Apr.23];7(3):21-9. Available from: https://www.ijdra.com/index.php/journal/article/view/332
Issue
Vol 7 No 3 (2019): VOLUME 7, ISSUE 3, 2019
Section
Review
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