Browsing Research Articles (School of Pharmacy) by Author "Litedu, Madira"
Now showing items 1-3 of 3
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Common defciencies found in generic Finished Pharmaceutical Product (FPP) applications submitted for registration to the South African Health Products Regulatory Authority (SAHPRA)
Moeti, Lerato; Litedu, Madira; Joubert, Jacques (Springer Nature, 2022)The aim of the study was to investigate the common defciencies observed in the Finished Pharmaceutical Product (FPP) section of generic product applications submitted to SAHPRA. The study was conducted retrospectively ... -
The implementation of a risk based assessment approach by the South African Health pProducts Regulatory Authority (SAHPRA)
Moeti, Lerato; Litedu, Madira; Joubert, Jacques (Springer, 2023)An extensive backlog of pending regulatory decisions is one of the major historical challenges that the South African Health Products Regulatory Authority (SAHPRA) inherited from the Medicine Control Council (MCC). Revising ... -
Regulatory registration timelines of generic medicines in South Africa: Assessment of the performance of SAHPRA between 2011 and 2022
Moeti, Lerato; Litedu, Madira; Joubert, Jacques (Springer, 2023)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 ...