Monthly Report – Sealed Sources
21 Nov General Information Medical Devices And IVDs
Posted at 12:20h
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This document has been archived....
21 Nov Guideline For Access To And Control Of Medical Devices And IVDs
Posted at 12:08h
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This document has been archived....
10 Nov Risk Management Plans for Medicines for Human Use
Posted at 09:46h
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This document has been prepared to serve as a guideline to the holders of certificate of registration/applicants on the Authority’s requirements regarding risk management plans for medicines, including biological medicines, in South Africa. It represents SAHPRA’s current thinking on the safety, quality and efficacy of...
25 Oct Common deficiencies found in API section of Non-Sterile Generic Products submitted for registration to SAHPRA
Posted at 16:15h
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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...
25 Oct Bioequivalence Common Deficiencies in Generic Products Submitted for Registration to SAHPRA
Posted at 16:10h
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Bioequivalence Common Deficiencies in Generic Products Submitted for Registration to SAHPRA - Moeti et al., Therapeutic Innovation and Regulatory Science. 2022 ...
25 Oct Common deficiencies found in generic FPP applications submitted for registration to SAHPRA
Posted at 15:52h
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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...
25 Oct South African Regulatory Authority: The Impact of Reliance on the Review Process Leading to Improved Patient Access
Posted at 15:39h
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South African Regulatory Authority: The Impact of Reliance on the Review Process Leading to Improved Patient Access - Keyter et al. Frontiers in Pharmacy, 2021...
24 Oct Topical corticosteroids – DHCPL – Risk of withdrawal reactions
Posted at 12:37h
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2022 Oct...