A New Drug Approval Process in Europe: A Review

  • Krishnasis Chakraborty


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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How to Cite
Chakraborty, K. “A New Drug Approval Process in Europe: A Review”. International Journal of Drug Regulatory Affairs, Vol. 7, no. 3, Sept. 2019, pp. 21-29, doi:10.22270/ijdra.v7i3.332.