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