Regulatory registration timelines of generic medicines in South Africa: Assessment of the performance of SAHPRA between 2011 and 2022

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dc.contributor.authorMoeti, Lerato
dc.contributor.authorLitedu, Madira
dc.contributor.authorJoubert, Jacques
dc.date.accessioned2023-05-08T11:02:04Z
dc.date.available2023-05-08T11:02:04Z
dc.date.issued2023
dc.description.abstractVarious 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.en_US
dc.identifier.citationMoeti, 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/s40545-023-00537-0en_US
dc.identifier.issn2052-3211
dc.identifier.urihttps://doi.org/10.1186/s40545-023-00537-0
dc.identifier.urihttp://hdl.handle.net/10566/8898
dc.language.isoenen_US
dc.publisherSpringeren_US
dc.subjectSouth African Health Products Regulatory Authority (SAHPRA)en_US
dc.subjectPharmaceuticalsen_US
dc.subjectMedicine regulatoryen_US
dc.subjectHealth professionalsen_US
dc.titleRegulatory registration timelines of generic medicines in South Africa: Assessment of the performance of SAHPRA between 2011 and 2022en_US
dc.typeArticleen_US

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