SAHPRA is an entity of the National Department of Health, created by the South African Government to ensure that the health and well-being of human and animal health is at its core.

SAHPRA assumed the roles of both the Medicines Control Council (MCC) as well as the Directorate of Radiation Control (DRC) which were housed at the National Department of Health (NDoH). Subsequently, SAHPRA was constituted as an independent entity that reports to the National Minister of Health through its Board.

SAHPRA's Core Business

SAHPRA is tasked with regulating (monitoring, evaluating, investigating, inspecting and registering) all health products. This includes clinical trials, complementary medicines, medical devices and in vitro diagnostics (IVDs). Furthermore, SAHPRA has the added responsibility of overseeing radiation control in South Africa. SAHPRA’s mandate is outlined in the Medicines and Related Substances Act (Act No 101 of 1965 as amended) as well as the Hazardous Substances Act (Act No 15 of 1973).

SAHPRA has three pillars to ensure that medicines, medical devices and IVDs meet the requisite standards to protect the health and well-being of South Africans:

• Safety
• Efficacy
• Quality

Vision

An agile and responsive African health products regulator that is globally recognised as an enabler of access to safe, effective and quality health products in South Africa.

Mission

To promote access to health products and protect human and animal health in South Africa through making science-based regulatory decisions.