The South African regulatory landscape for clinical trials is in a state of flux at the moment as the Board for the New South African Health Products Regulatory Authority (SAHPRA) has been announced. See links below to relevant sites and reources and to our news page for latest publications & annoucememnts from SAHPRA.

 

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

 

See the South African Clinical Research Association (SACRA) resources for news from the South African Medicines Control Council and other useful links

 

See the UCT Clinical Research Centre’s toolkit for regulatory and other approvals

 

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. This website provides well-documented, up-to-date regulatory information for multiple countries in a single place. ClinRegs is intended to serve as a central resource and time-saver for persons involved in planning and implementing international clinical research. ClinRegs’ easy-to-navigate functionality enables users to obtain a digestible overview of a country’s regulatory requirements related to a specific topic and to compare requirements across multiple countries. Additionally, ClinRegs provides links to official regulations and other key resources related to international clinical research to facilitate independent analysis. We have linked to their South African webpage which is reviewed by staff from the South African Regional Faculty of GHT and the UCT Clinical Research Centre

 

The Pan African Clinical Trials Registry (PACTR)

The Pan African Clinical Trials Registry (PACTR) is a regional register of clinical trials conducted in Africa. The registry is an African initiative 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.