Drug approval process in US, Europe and India and its regulatory requirements: A Review
Journal Title: International Journal of Drug Regulatory Affairs - Year 2018, Vol 6, Issue 3
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).
Authors and Affiliations
Krishnasis Chakraborty, Kavita Yadav
Keywords
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- EP ID EP426930
- DOI 10.22270/ijdra.v6i3.266
- Views 122
- Downloads 0
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