Browsing by Author "Litedu, Madira"

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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)
    (Springer Nature, 2022) Moeti, Lerato; Litedu, Madira; Joubert, Jacques
    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 over a 7-year period (2011–2017) for products that were fnalised by the Pharmaceutical and Analytical pre-registration Unit.There were 3148 fnalised products in 2011–2017, 667 of which were sterile while 2089 were non-sterile. In order to attain a representative sample for the study, statistical sampling was conducted. Sample size was obtained using the statistical tables found in literature and confrmed by a sample size calculation with a 95% confdence level. The selection of the products was according to the therapeutic category using the multi-stage sampling method called stratifed-systematic sampling. This resulted in the selection of 325 applications for non-sterile products and 244 applications for sterile products. Subsequently, all the defciencies were collected and categorised according to Common Technical Document (CTD) subsections of the FPP section (3.2.P).
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    The implementation of a risk based assessment approach by the South African Health pProducts Regulatory Authority (SAHPRA)
    (Springer, 2023) Moeti, Lerato; Litedu, Madira; Joubert, Jacques
    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 and implementing new regulatory pathways is one of the strategic mechanisms that SAHPRA employs to circumvent this problem. To alleviate the backlog, the use of a new review pathway termed the risk-based review on the scientifc quality and bioequivalence assessments was explored. The objective of the study was to articulate the risk-based assessment (RBA) pathway, to determine robust criteria for the classifcation of the levels of risk for medicines, and to defne the improved process to be followed in the assessment and approval of medicines.
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    Regulatory registration timelines of generic medicines in South Africa: Assessment of the performance of SAHPRA between 2011 and 2022
    (Springer, 2023) Moeti, Lerato; Litedu, Madira; Joubert, Jacques
    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.