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, 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...
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...
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...
Dear Stakeholder, You are invited to the South African Health Products Regulatory Authority’s (SAHPRA’s) Regulatory Technical Forum (RTF) Meeting. Areas of discussion on the agenda include: Medicines (Allopathic) Inspectorate Updates Veterinary Medicines Complementary Medicines Inspectorate and Regulatory Compliance Medical Devices & IVDs Legislation/Guidelines for Comment/Implementation IT Upgrade ...
The South African Health Products Regulatory Authority (SAHPRA) hosted a consultative meeting with industry to communicate updates, compliance to legislative requirements, improve the application process, and enhance overall client service and relations. Purpose of the webinar: Update on applicable fees SAHPRA’s services and processes Annual retention...
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...
Inspired by the Digital Health Africa (DHA) Conference 2025, a side event on the Digital Transformation of Medicines Regulation in Africa was hosted collaboratively by the South African Health Products Regulatory Authority (SAHPRA) and Pharmacometrics Africa. The event featured insightful presentations and dynamic discussions aimed...
The South African Health Products Regulatory Authority (SAHPRA) hosted a webinar to provide industry with updates on SAHPRA’s Engagement Portal. The session focused on various areas aimed at improving overall user support. Attendees learned about: Clarifications on industry fees Context and support volumes Visibility of API...
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...
