Embargo: Immediate release Pretoria, 1 December 2025 – The South African Health Products Regulatory Authority (SAHPRA) has officially been accepted as a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), following an ICH assessment of compliance with requirements...
SAHPRA offices will be closed for the festive season from 12:00 on Wednesday, 24 December 2025 and will re-open at 08:00 on Monday, 05 January 2026. Please note: Dates, placed within brackets for various email addresses, will guide stakeholders to the timeframes that emails will be processed. Dates,...
[Embargoed] Johannesburg, 19 November 2025 – As artificial intelligence (AI) increasingly enters the mental health space, from therapy chatbots to diagnostic tools, the world faces a critical question: can AI expand access to care without putting people at risk? At the G20 Social Summit in Johannesburg,...
Pretoria, 11 November 2025 – The South African Health Products Regulatory Authority (SAHPRA) cautions members of the public against purchasing or using GLP-1 (glucagon-like peptide-1) products that are being promoted and sold on various social media platforms. These products are being promoted to assist with...
Pretoria, 27 October 2025 – The South African Health Products Regulatory Authority (SAHPRA) is pleased to announce the registration of Lenacapavir. Lenacapavir is an antiviral medicine that is recommended, in combination with safer sex practices, for pre-exposure prophylaxis (PrEP) to prevent HIV-1 infection in adults...
Picture a young girl watching her parents navigate the daily maze of diabetes management- checking blood glucose levels, calculating insulin doses, searching for affordable medications, and hoping that tomorrow’s treatment will be accessible. In that quiet observation lies the seed of a revolution, the birth...
Pretoria, 15 October 2025 – The South African Health Products Regulatory Authority (SAHPRA) and the Health Professions Council of South Africa (HPCSA) signed a Memorandum of Agreement (MOA) on 18 August 2025 for five years. The main objective of this MOA is to enable collaboration...
Dear Stakeholders, Please be advised that the SAHPRA Pretoria Office is currently operating remotely. For any enquiries, we kindly request that you email or call the relevant unit directly. Our teams remain fully available to assist you during this period. Access our Key Contacts here. We apologise for...
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, 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...
