Opportunities at South African Health Products Regulatory Authority (SAHPRA)

The South African Health Products Regulatory Authority (SAHPRA) is a Schedule 3A public entity established under the National Department of Health. Its primary role is to safeguard both human and animal health by regulating health products across South Africa. Industry and Core Functions SAHPRA operates within the medical regulation industry, responsible for ensuring that health products meet strict standards for safety, efficacy, and quality. Its core functions include monitoring, evaluating, investigating, inspecting, and registering health products such as medicines, medical devices, complementary medicines, and in vitro diagnostics (IVDs). The authority also oversees the licensing of manufacturers, wholesalers, and distributors of regulated products, as well as radiation-emitting devices and radioactive nuclides. In addition, SAHPRA regulates and approves clinical trials in line with national health policies and regulatory guidelines. The organisation’s mission is to promote access to safe, effective, and quality health products through science-based regulatory decisions. Its values are built on Ubuntu, responsiveness, integrity, transparency, efficiency, excellence, and collaboration. Mandate and Legislative Framework SAHPRA’s regulatory mandate is derived from the Medicines and Related Substances Act (Act 101 of 1965, as amended) and the Hazardous Substances Act (Act 15 of 1973). These statutes empower SAHPRA to monitor, regulate, and control health-related products in the public interest, including veterinary medicines to ensure both human and animal health are protected. Additionally, SAHPRA functions within the broader constitutional and health policy landscape of South Africa, as outlined in the Constitution and the National Health Act of 2003. Organisation and Location SAHPRA operates from its head office in Pretoria, with satellite offices in Cape Town and Durban. This national footprint enables the authority to effectively perform regulatory oversight and serve stakeholders throughout the country. SAHPRA was created to replace the former Medicines Control Council (MCC) and the Directorate of Radiation Control (DRC), consolidating their responsibilities into a single, more robust regulatory body. It operates independently but reports to the Minister of Health through its Board.