The Regulatory Review Process in South Africa: Challenges and Opportunities for a New Improved System

Therapeutic Innovation & Regulatory Science
Andrea KeyterStuart Walker

Abstract

The aims of this study were to assess the regulatory review process in South Africa from 2015 to 2017, identify the key milestones and timelines; evaluate the effectiveness of measures to ensure consistency, transparency, timeliness, and predictability in the review process; and to provide recommendations for enhanced regulatory practices. A questionnaire was completed by the Medicines Control Council (MCC) to describe the organization of the authority, record key milestones and timelines in the review process and to identify good review practices (GRevPs). Currently, the MCC conducts a full assessment of quality, efficacy, and safety data in the review of all applications. The overall regulatory median approval time decreased by 14% in 2017 (1411 calendar days) compared with that of 2016, despite the 27% increase in the number of applications. However, the MCC has no target for overall approval time of new active substance applications and no targets for key review milestones. Guidelines, standard operating procedures, and review templates are in place, while the formal implementation of GRevPs and the application of an electronic document management system are planned for the near future. As the MCC transitions to the newly e...Continue Reading

Citations

Jan 9, 2019·Frontiers in Pharmacology·Andrea KeyterStuart Walker
Jan 3, 2021·Therapeutic Innovation & Regulatory Science·Tariro SitholeStuart Walker
Dec 2, 2020·Therapeutic Innovation & Regulatory Science·Tariro SitholeStuart Walker
Apr 3, 2021·Journal of Pharmaceutical Policy and Practice·K NarsaiA K Mantel-Teeuwisse
Aug 5, 2021·British Journal of Clinical Pharmacology·Boitumelo Semete-MakokotlelaGoonaseelan Colin Pillai

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