2018•International Journal of Drug Regulatory AffairsOpen access

Drug approval process in US, Europe and India and its regulatory requirements: A Review

Krishnasis Chakraborty, Kavita Yadav

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 US Food and Drug Administration (UDFDA), European Medical Agency (EMA) and Central Drug Standard Control Organization (CDSCO) (1).

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Key concepts: Regulatory science, Regulatory affairs, Marketing authorization, Regulatory agency, Food and drug administration, Authorization, Agency (philosophy), Business