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A new drug approval process in Europe: A review Chakraborty Krishnasis* Department of Quality Assurance, Al-Ameen College of Pharmacy, Lalbagh Road, Bangalore, India - 560027 *Corresponding author Tel.: +91-9632703191, E-mail address: krishnasis07p@gmail.com (K. Chakraborty)
Online published on 24 May, 2021. 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). Top Keywords Drug Approval, Regulatory Requirements, EMA, Marketing Authorization Application (MAA), CHMP, CMS, RMS. Top | |
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