Archive

15 Jul The value of a structured, systematic approach to benefit-risk assessment of medicines – SAHPRA case study

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This study investigates the utility of the Universal Methodology for Benefit-Risk Assessment (UMBRA) framework within the South African Health Products Regulatory Authority (SAHPRA) to determine whether adopting a structured approach improves consistency, transparency, and quality in benefit-risk assessments of new chemical entities (NCEs). The UMBRA...

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03 Mar The Economic Impact of Reliance on an African Medicines Regulatory Authority

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Background and Objectives The inherited backlog of 16,000 medicines applications of the South African Health Products Regulatory Authority (SAHPRA) was cleared through facilitated review pathways that included reliance on prior work by trusted regulators. This research aimed at determining the economic impact of reliance on...

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28 Jan Empowering African Expertise: Enhancing Safety Data Integration and Signal Detection for COVID‑19 Vaccines

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Empowering African Expertise: Enhancing Safety Data Integration and Signal Detection for COVID‑19 Vaccines Through the African Union Smart Safety Surveillance Joint Signal Management Group Victoria Prudence Nambasa · Hannah May Gunter · Modupe Bamidele Adeyemo · Neetesh Yanish Bhawaneedin · Marc Blockman · George Tsey Sabblah ,...

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25 Oct Common deficiencies found in API section of Non-Sterile Generic Products submitted for registration to SAHPRA

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Common deficiencies found in API section of Non-Sterile Generic Products submitted for registration to SAHPRA - Moeti et al., Therapeutic Innovation and Regulatory Science. 2021...

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25 Oct Bioequivalence Common Deficiencies in Generic Products Submitted for Registration to SAHPRA

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Bioequivalence Common Deficiencies in Generic Products Submitted for Registration to SAHPRA - Moeti et al., Therapeutic Innovation and Regulatory Science. 2022 ...

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25 Oct Common deficiencies found in generic FPP applications submitted for registration to SAHPRA

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Common deficiencies found in generic Finished Pharmaceutical Product (FPP) applications submitted for registration to SAHPRA, Moeti et al., Journal of Pharmaceutical Policy and Practice (2022), 15:6...

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25 Oct South African Regulatory Authority: The Impact of Reliance on the Review Process Leading to Improved Patient Access

Posted at 15:39h in

South African Regulatory Authority: The Impact of Reliance on the Review Process Leading to Improved Patient Access - Keyter et al. Frontiers in Pharmacy, 2021...

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