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Over the last thirty years, South Africa has developed a medicines regulatory authority with internationally recognized standing.  Over the past five years, it has been transformed in order to improve its performance and regulatory processes.  The Medicines Control Council (MCC) is a statutory body that was established in terms of the Medicines and Related Substances Control Act, 101 of 1965, to oversee the regulation of medicines in South Africa.  It is appointed by the Minister of Health and its main purpose is to safeguard and protect the public through ensuring that all medicines that are sold and used in South Africa are safe, therapeutically effective and consistently meet acceptable standards of quality.

 The History of Medicine Regulation in South Africa

 ·        So far, more than 20 000 medicines have been approved.  Since the establishment of the Medicines Control Council, more than 220 meetings have been held to decide on the registration of medicines.  

·        Applications for more than 11 800 complementary medicines have been submitted for evaluation by the Complementary Medicines Committee.

·        The South African Pharmacy Council has licensed 300 wholesalers and distributors.  These must still be licensed by the Medicines Control Council in terms of the Medicines Act.

·        The Medicines Control Council approves more than 280 clinical trials annually.

Medicines regulation in South Africa

 The Medicines Control Council applies standards laid down by the Medicines and Related Substances Control 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.  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, Medicines Regulatory Affairs, within the Department of Health.  There are four Directorates, which are largely responsible for co-ordination and execution of various activities.  There is also a Deputy Registrar who performs functions as determined by the Registrar.

 The staff complement of Medicines Regulatory Affairs 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 11 technical committees, with 146 members from various institutions in the country.  These include the Clinical Committee, Pharmaceutical and Analytical Committee, Clinical Trials Committee, Scheduling Committee, Veterinary Committee, Pharmacovigilance Committee, Biological Committee, Complementary Medicines Committee, and African Traditional Medicines 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 Control Act 101 of 1965 defines a medicine:

 as any substance or mixtures of substances used or purporting to be suitable for use of manufacture or sold for use in -:

 a)     diagnosis, treatment, mitigation, modification, or prevention of a disease, or abnormal physical or mental state, or the symptoms thereof in man, or

b)     restoring, correcting, or modifying any somatic or psychic or organic function in man, and includes any veterinary medicine.

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.