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...
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...
Please note that SAHPRA Head Office, including Cape Town and Durban Regional Offices will be unavilable today, 29 November 2024 due to the organisation's Annual General Meeting. If you require assistance, please use applicable contacts from Key Contacts: https://www.sahpra.org.za/key-contacts/ ...
SAHPRA offices will be closed for the festive season from 12:00 on Tuesday, 24 December 2024 and will re-open on Monday, 06 January 2025. Please note: Dates, placed within brackets for various email addresses, will guide stakeholders to the timeframes that emails will be processed. Dates, placed within...
Pretoria, 21 November 2024 – The South African Health Products Regulatory Authority (SAHPRA) is aware of a quality issue in a batch of YAZ Plus contraceptives (Batch No. WEW96J distributed on 09 and 24 November 2023) which has resulted in the incorrect arrangement of tablets...
Pretoria, 08 November 2024 –The South African Health Products Regulatory Authority (SAHPRA) is concerned about the proliferation of falsified, compounded and substandard Glucagon-like Peptide (GLP-1)-containing products being made available to the public via websites, social media platforms and other informal channels. These pose a health...
