Article

Regulatory Harmonisation In South Africa: A Critical Overview
Shaik Azeem Ahmed* , S.B.Puranik

Details

Author

Shaik Azeem Ahmed*

ISSN

2319-5622

DOI

doi.org/10.5281/zenodo.3923724

Published on

Jun 30, 2020

Abstract

The purpose of this article is to present a concise overview of changes in variation of South African Health Products Regulatory Authority (SAHPRA) and its adoption of variation policies from European Medicines Agency (EMA). Along with which we have also discussed about the exclusions, additions of variation guidelines in different aspects. In this article, along with variation changes by SAHPRA, it also includes about different reliance pathways adopted and also about difference in document and data requirements by the authority for reliance based evaluations and principles involved in it. Latest documents to be involved as per Reliance Models have also been discussed for e.g. Summary of Critical Regulatory Elements (Score) Document along with Bioequivalence Trial Information Form, Bio waiver and Bio study forms which are also mandatory for New Drug Submissions and Resubmissions along the details of data to be submitted to the agency and the pathways of registration an applicant can avail, categories a drug can be registered by SAHPRA . These forms include details about the drug summary and different studies carried out on the drug. It also includes list of SAHPRA’s recognised regulatory authorities (RRA). Finally the article includes about harmonisation by SAHPRA in its variations guidelines and adoption of different policies wherever required.

Keywords

SAHPRA, EMA, SCORE, BTIF and RRA

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