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...
[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...
Pretoria, 28 September 2025 – The South African Health Products Regulatory Authority (SAHPRA) wishes to reassure the public that paracetamol remains a safe and recommended option for the relief of pain and fever during pregnancy, when used short-term at recommended doses. Paracetamol is one of the...
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...
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...
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...
