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.
The historical trajectory:
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 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:
It is these three pillars that define the ethos of SAHPRA.
An agile, conscientious and socially transformative, globally positioned health products regulator with sustainable positive impact on long and healthy lives of all those living in South Africa.
To safeguard public and animal health by licensing of safe, effective and good quality medicines, medical devices, IVD’s, radiation devices and radioactive materials. Further, to monitor clinical trials, maintain vigilance and ensure regulatory compliance of these health products in South Africa.