Useful Links – South Africa
MEDICINES CONTROL COUNCIL (MCC)
Clinical trials and registration of orthodox / allopathic medicines are subject to the terms of the Medicines and Related Substances Act; Act 101 of 1965 as amended.
The Medicines Control Council (MCC) is a local statutory body constituted in compliance with Act 101, which regulates the performance of clinical trials and registration of medicines and medical devices in South Africa. The Medicines Regulatory Authority (MRA) is the secretariat to the MCC which coordinates applications and forwards them to the relevant MCC subcommittee to ensure that all clinical trials of both non-registered medicines and new indications of registered medicines comply with the necessary requirements for safety, quality and efficacy.
All clinical trials are conducted in according to the South African equivalent of ICH GCP.
NATIONAL HEALTH RESEARCH COMMITTEE
The National Health Research Committee (NHRC) is a statutory body established in terms of the National Health Act, 2003.
The National Health Research Committee is tasked with determining the type of research to be carried out by the pubic health authorities and ensuring that health research is focused on priority health problems. The Committee also advises the Minister of Health on national strategies for health research and co-ordinates the research activities of public health authorities.
NATIONAL HEALTH RESEARCH ETHICS COUNCIL
The NHREC’s function is to give direction on ethical issues relating to health and in developing guidelines for the conduct of research involving humans in South Africa. The Council observes and advises on international developments in health ethics issues through liaison with relevant international organisations. The Council also regulates the academic and private research ethics committees in South Africa. As for the National Health Research Committee, the NHREC is a statutory body established in terms of the National Health Act, 2003
Accreditation by the NHREC is mandatory for all Ethics Committees in South Africa who approve health research in humans.
SOUTH AFRICAN CLINICAL TRIALS REGISTER
The South African Clinical Trials Register (SANCTR) provides the South African public with updated information about clinical trials being conducted in South Africa. In order to fulfil requirements for approval, all clinical trials must be registered on this publicly accessible website.