SAHPRA

The South African Health Products Regulatory Authority (SAHPRA) operates as an independent entity under the National Department of Health, established to safeguard the well-being of humans and animals in South Africa. Its core responsibility involves regulating health products, which encompasses the monitoring and evaluation of medicines, medical devices, complementary medicines, clinical trials, and in vitro diagnostics. In addition, SAHPRA oversees the licensing of manufacturers, wholesalers, and distributors, ensuring compliance with safety and efficacy standards defined by the Medicines and Related Substances Act.

With a mission to promote accessibility to safe and quality health products, SAHPRA adheres to three foundational pillars: safety, efficacy, and quality. This authority is also tasked with radiation control, reflecting its comprehensive role in public health protection. Committed to transparency and integrity, SAHPRA's vision is to be recognized globally as a leading health products regulator, facilitating access to essential health services while upholding the highest standards of safety and efficacy.