Department of Quality Assurance, Al-Ameen College of Pharmacy, Lalbagh road, Bangalore, India
*Corresponding author Tel.: +91-9632703191; E-mail address: krishnasis07p@gmail.com (Krishnasis Chakraborty)
Online published on 17 September, 2019.
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 US Food and Drug Administration (UDFDA), European Medical Agency (EMA) and Central Drug Standard Control Organization (CDSCO) (1).
Drug Approval, Regulatory Requirements, USFDA, EMA, CDSCO, DCGI
