Regulatory Framework


The regulatory authority in South Africa, known as the Medicines Control Council, was established in terms of the Medicines and Related Act 101 of 1965 to oversee the regulations of medicines in South Africa. This Regulatory Authority will soon be known as the South African Health Products Regulatory Authority.


The National Health Research Ethics Council (NHREC), a council that regulates matters of research ethics, also regulates the academic and private research ethics committees in South Africa.


The application for approvals to the regulatory authority and ethics committee is a parallel process. All health research conducted in South Africa must be registered in the South African National Clinical Trials register. Each clinical trial on the register is issued with a unique number.