South African Health Products Regulatory Authority

Overview

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 No 101 of 1965 as amended, as well as the Hazardous Substances 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, and quality. It is these three pillars that define the ethos of SAHPRA.