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

  • Krishnasis Chakraborty Al-Ameen College of Pharmacy, bangalore
  • Kavita Yadav


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).

Keywords: Drug Approval, Regulatory Requirements, USFDA, EMA, CDSCO, DCGI.


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How to Cite
Chakraborty, K., and K. Yadav. “Drug Approval Process in US, Europe and India and Its Regulatory Requirements: A Review”. International Journal of Drug Regulatory Affairs, Vol. 6, no. 3, Sept. 2018, pp. 31-39, doi:10.22270/ijdra.v6i3.266.