Welcome to the Medicines Control Council of South-Africa
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.
History of Medicine Regulation in South Africa
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.
for more than 11 800 complementary medicines have been
submitted for evaluation by the Complementary Medicines
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.
Medicines Control Council approves more than 280
clinical trials annually.
regulation in South Africa
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.
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.
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.
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.
structure of Council and its committees is described
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
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.
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:
any substance or mixtures of substances used or
purporting to be suitable for use of manufacture or sold
for use in -:
diagnosis, treatment, mitigation, modification,
or prevention of a disease, or abnormal physical or
mental state, or the symptoms thereof in man, or
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
Further, all veterinary medicines must be
registered in terms of the Act excluding stock remedies
registered in terms of Act 36.