The South African regulatory landscape for clinical trials falls within the South African Health Products Regulatory Authority (SAHPRA), 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. Trials should also have ethical approval and be registered through the SA National Clinical Trials Register

South African Health Products Regulatory Authority (formerly Medicine Control Council)

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 and radiation control. 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)

South African Clinical Research Association (SACRA)

SACRA is a non-profit organisation with paid membership representing the clinical research industry in South Africa. Join SACRA and recieve regular emails about new South African regulatory requirements and guidance

National Institute of Allergy and Infectious Diseases

The NIAID ClinRegs website provides an online database of country-specific clinical research regulatory information designed to enable users to explore regulations within a country and compare requirements across countries. The South African Regional Faculty of GHT helpd to keep the South African page up to date

The Pan African Clinical Trials Registry (PACTR)

PACTR is a regional register of clinical trials conducted in Africa serving the needs of Africans. It provides an open-access platform where clinical trials can be registered free of charge. The PACTR aims to increase clinical trial registration in Africa by developing awareness of the need to register trials and supporting trialists during registration

The South African National Clinical Trials Register (SANCTR)

(SANCTR) provides the public with updated information on clinical trials on human participants being conducted in South Africa. The Register provides you with information on a trials purpose; who can participate, where the trial is located, and contact details