SAHPRA undergoes training to strengthen its regulatory capabilities

Pretoria, 22 May 2025 –The South African Health Products Regulatory Authority (SAHPRA), having applied Reliance on the World Health Organization (WHO) PQ assessment under Emergency Use Listing, has listed the first mpox (monkeypox) in vitro diagnostic (IVD). This serves as an important step in improving global access to mpox testing by using a reliance process. The emergency use approval of the Alinity m MPX...

Pretoria, 04 April 2025 –The South African Health Products Regulatory Authority (SAHPRA) has joined the Medical Device Single Audit Programme (MDSAP), an international audit programme of medicines and medical device regulators aimed at improving efficiencies in the regulation of medical device manufacturers by engaging in work...

Pretoria, 24 March 2025 –The South African Health Products Regulatory Authority (SAHPRA), in partnership with Pharmacometrics Africa and the Department of Pharmacy and Pharmacology at the University of the Witwatersrand, proudly announces the graduation of the fourth cohort from the Clinical Assessors Short Course —...

Cairo, Egypt, 4 February 2025: The Africa Centres for Disease Control and Prevention (Africa CDC) and African Union Development Agency – New Partnership for Africa’s Development (AUDA-NEPAD) are proud to announce the signing of a Memorandum of Understanding (MoU) among Africa’s WHO Maturity Level 3...

Pretoria, 17 January 2025 – The South African Health Products Regulatory Authority (SAHPRA) has recommended that the product information of medroxyprogesterone acetate (MPA)-containing products be amended by updating the safety warnings to include the potential risk of meningioma. MPA is a synthetic oral and injectable form...