Regulatory registration timelines of generic medicines in South Africa: Assessment of the performance of SAHPRA between 2011 and 2022
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Date
2023
Journal Title
Journal ISSN
Volume Title
Publisher
Springer
Abstract
Various regulatory authorities are experiencing backlogs of applications which result in delayed access
to medicines for patients. The objective of this study is to critically assess the registration process utilised by SAHPRA
between 2011 and 2022 and determine the fundamental root causes for the formation of a backlog. The study also
aims to detail the remedial actions that were undertaken which resulted in the development of a new review pathway
termed the risk-based assessment approach for regulatory authorities experiencing backlogs to implement. A sample of 325 applications was used to evaluate the end-to-end registration process employed for
the Medicine Control Council (MCC) process between 2011 and 2017; 129 applications were used for the backlog
clearance project (BCP) between 2019 and 2022; 63 and 156 applications were used for the risk-based assessment
(RBA) pilot studies in 2021 and 2022, respectively. The three processes are compared, and the timelines are discussed
in detail.
Description
Keywords
South African Health Products Regulatory Authority (SAHPRA), Pharmaceuticals, Medicine regulatory, Health professionals
Citation
Moeti, L. et al. (2023). Regulatory registration timelines of generic medicines in South Africa: Assessment of the performance of SAHPRA between 2011 and 2022. Journal of Pharmaceutical Policy and Practice, 16, 34. https://doi.org/10.1186/s40545-023-00537-0