Pretoria, 27 August 2025 –The South African Health Products Regulatory Authority (SAHPRA) has approved a molecular test kit for Mpox , Cobas MPXV, for use on the Cobas 6800/8800 Systems, within nine working days through a collaborative and harmonised review process under the African Medicines Regulatory Harmonisation (AMRH). Rapid...
Pretoria, 21 August 2025 – The South African Health Products Regulatory Authority (SAHPRA) is proud to announce that it has obtained a clean audit outcome from the Auditor-General of South Africa (AGSA) for the 2024/2025 financial year, following its first clean audit for the 2023/24...
Pretoria, 15 July 2025 – The South African Health Products Regulatory Authority (SAHPRA) was notified of the Lancet Global Health 2025; 13: e1250, an investigational study and its findings on substandard anti-cancer medications in Sub-Saharan African countries, including Ethiopia, Kenya, Malawi, and Cameroon. This study...
Pretoria, 02 July 2025 – The South African Health Products Regulatory Authority (SAHPRA) welcomes its newly appointed Board Members. The SAHPRA Board is appointed by the Minister of the National Department of Health, Dr Aaron Motsoaledi. The appointment is in accordance with section 2C(2) of...
Pretoria, 18 June 2025 Meeting highlights: Crisis-Driven Resilience and Standards: SAHPRA maintained strict scientific standards and operational integrity during the COVID-19 pandemic, focusing on responsiveness without compromising safety or quality, while also strengthening collaboration with national and international stakeholders. Support for Local Manufacturing and Strategic Vision: A major 2025 priority...
Cape Town - The Radiation Control (RadCon) Unit of the South African Health Products Regulatory Authority (SAHPRA) attended a Search and Secure training held by the Office of Radiological Security (ORS) within the USA’s Department of Energy during 19 – 23 May 2025 in Cape...
A Thought Leadership Article by SAHPRA's CEO, Dr Boitumelo Semete-Makokotlela Introduction Pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine-related problems, which play a crucial role in ensuring public safety. The South African Health Products...
Pretoria, 11 June 2025—The South African Health Products Regulatory Authority (SAHPRA) is warning the public to be vigilant and cautious when engaging with service providers who claim to be licensed by SAHPRA. SAHPRA has learned that individuals and companies are operating unethically by presenting falsified...
04 June 2025 - The South African Health Products Regulatory Authority (SAHPRA) recently visited the Egyptian Drug Authority (EDA) at their Cairo Offices for an intensive training programme to capacitate the Regulator on how to achieve recognition for the World Health Organization (WHO) Global Benchmarking...
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...
