Archive

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

Posted at 09:56h in

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 ,...

Read More

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

Posted at 16:15h in

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...

Read More

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

Posted at 16:10h in

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

Read More

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

Posted at 15:52h in

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...

Read More

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...

Read More