Over the last thirty years, South Africa has developed a medicines
regulatory authority with internationally recognized standing.
In recent 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, (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.
To date, 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
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. A Deputy Registrar 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, (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.