Chapter 13 - Clinical Trials in South Africa

Abstract

This chapter discusses clinical trials in South Africa. The establishment of the Medicines Control Council (MCC) in 1965 and the country's first international symposium on drug development in 1972 both stimulated clinical research activity. The Medicines and Related Substances Act, 1965 (Act 101 of 1965) made provision for the establishment of the MCC, a statutory body tasked with regulating pharmaceutical products in South Africa, Clinical Trials Committee (CTC), responsible for review of clinical trial applications. MCC and its substructures are provided by the Medicine Regulatory Authority (MRA) cluster, headed by the Registrar of Medicines. The MRA encompasses four units, including an inspectorate conducting good manufacturing practice (GMP) and good clinical practice (GCP) inspections and the Clinical Trials Unit. National harmonization began when the National Research Ethics Council (NHREC) was created as a statutory body responsible for establishing guidelines and setting norms and standards for ethical review of health research in South Africa. Since most clinical trials conducted in South Africa are sponsored by international companies, trial sites, local offices of pharmaceutical companies, and CROs are all subject to audit by international regulatory authorities and the MCC's inspectorate. The Informal Clinical Trial Network (iCTN) is a smaller group of managers from pharmaceutical companies, large trial sites, SMOs, and CROs who meet every two to three months to discuss new challenges and work collectively toward resolving issues that affect the industry nationally. The Association of Clinical Research Professionals (ACRP) has a chapter in South Africa, but its membership is very small.