Over the last fifty years, South Africa has developed a medicines regulatory authority with internationally recognised standing.
The Medicines Control Council applies standards laid down by the Medicines and Related Substances Act, (Act 101 of 1965) which governs the manufacture, distribution, sale, and marketing of medicines. The prescribing and dispensing of medicines is controlled through the determination of schedules for various medicines and substances.
The MCC operates through external experts who are members of Council Committee structures. Most experts evaluate data sets submitted by the pharmaceutical industry for purposes of registration. Many of these evaluators are from various academic institutions, mainly medical and pharmacy schools.
The office of the Registrar provides administrative and technical support to Council and its activities. The Registrar is also an executive secretary to Council. The Registrar’s office is a Chief Directorate/Cluster, Food Control, Pharmaceutical Trade & Product Regulation, within the Department of Health. There are four Directorates, which are largely responsible for co-ordination and execution of various activities. The cluster is, therefore, secretariat to the Council.
The staff complement of the Cluster includes doctors, pharmacists, veterinarians, other scientists and administrative staff. A certain amount of technical evaluation of generic medicines is performed in-house. It is anticipated that this will increase over time as use of generic medicines increases, in line with government policy of improving access to medicines.
The structure of Council and its committees is described below. The skills of Council and its committees are written into law and include expertise in toxicology and medicine safety, clinical pharmacology, biotechnology, pharmaceutics, internal medicine, virology, pharmaceutical chemistry, neonatology, paediatrics, immunology, veterinary science, complementary medicines and law.
The Council has 9 active technical committees, with 146 members from various institutions in the country. These include the Clinical Committee, Pharmaceutical and Analytical Committee, Clinical Trials Committee, Names & Scheduling Committee, Veterinary Clinical Committee, Pharmacovigilance Committee, Biological Medicines Committee, Complementary Medicines Committee, and Legal Committee.
The Council, in considering whether a medicine is suitable for use for its intended purpose, assesses its relative risk against the benefits. The Medicines and Related Substances Act, 1965 (Act 101 of 1965), defines a medicine as any substance or mixtures of substances used or purporting to be suitable for use or manufacture or sold for use in -:
All medicines for human use are subject to this law, including complementary and complementary biological medicines. Further, all veterinary medicines must be registered in terms of the Act, excluding stock remedies registered in terms of Act 36.