Overview of Drug Regulatory Affairs and Drug approval process in US, Europe, India and Canada: A Review

  • Aishwarya Patil student
  • Anjali Thakre

Abstract

Pharmaceutical drug regulatory affairs issues administer enlistment parameters of pharmaceutical products. It has an expansive range covering all parts of documentation and marketing in legitimized structure. DRA is a dynamic, remunerating field that incorporates both logical and lawful parts of medication advancement. DRA experts are committed people who invest heavily in their commitment to improving the health and quality of life of peoples. RA as calling is more extensive than enlistment of product; they prompt organizations both deliberately and actually at the most significant level.


Today, the administrative necessities for approval of another medication in the different nations of the world are very extraordinary. To create one single administrative methodology for marketing authorization application (MAA) of another medication product for different nations is most extreme troublesome assignment particularly for organizations with worldwide exercises. In this manner, it is imperative to know in detail the administrative necessities in every nation where a MAA ought to be submitted to build up an appropriate administrative technique before the accommodation so as to stay away from any significant troubles. The new medication approval is of two stage process, clinical preliminaries stage and Marketing approval of medication. This review article depends on procedures for drug approval in different countries like India, USA, Europe and Canada.

Keywords: Drug regulatory affairs, MAA, USFDA, CDSCO, EMA, Notice of Compliance (NOC), Notice of Deficiency (NOD), RMS, CMS, ANDA

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How to Cite
Patil, A., and A. Thakre. “Overview of Drug Regulatory Affairs and Drug Approval Process in US, Europe, India and Canada: A Review”. International Journal of Drug Regulatory Affairs, Vol. 8, no. 2, June 2020, pp. 36-43, doi:10.22270/ijdra.v8i2.401.