A comprehensive review on registration requirements for Drug Approval in India, South Africa and US

  • Veer J. Patel M.Pharm (Pharmaceutical Regulatory Affairs) Student, Graduate School of Pharmacy, Gujarat Technological University
  • Dasharath M. Patel Associate Professor, Graduate School of Pharmacy, Gujarat Technological University

Abstract

The drug approval process is country-specific. The regulatory framework of all the national regulatory agencies differ from one another in terms of administration and product specific guidelines for registration of drug and drug products in a particular country. Every national regulatory authority provides regulatory guidelines for drug or drug product registration and the pharmaceutical industries which rely upon these guidelines prepare drug applications along with all the required administrative, non-clinical and clinical data in the form of a technical dossier which is known as Common Technical Document. This Dossier is prepared either in an electronic format or in the paper submission format. This review focuses on the comparative study of the registration requirements for getting a drug approval in India, South Africa and United States of America. The significant differences between the technical requirements of these three markets have been discussed in detail.

Keywords: Central Drug Standard Control Organization (CDSCO), South African Health Products Regulatory Authority (SAHPRA), United States Food and Drug Administration (USFDA), Drug approval, New Drug Application (NDA), Common Technical Document (CTD), Dossier

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How to Cite
Patel, V. J., and D. M. Patel. “A Comprehensive Review on Registration Requirements for Drug Approval in India, South Africa and US”. International Journal of Drug Regulatory Affairs, Vol. 9, no. 1, Mar. 2021, pp. 62-71, doi:10.22270/ijdra.v9i1.456.