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Before a clinical trial
can be conducted, the sponsor has to submit an application to the
South African Medicines Control Council (MCC), and obtain approval.
This review process can take up to 4 or 5 months.
Moreover, approval is also required from an approved Ethics Committee. The Ethics Committee opinion will be provided within about 2 months.
The Guidelines for Good Clinical Practice and the Declaration of Helsinki
must be observed. All investigators must have clinical trial experience (i.e. they must at least have been a
co-investigator before) and must have attended a GCP course.
Clinical trials performed in Africa are registered in the African
Trials Register.
 Health
Care System |
The Department of
Health is committed to improving the quality of health care,
improving access to health care for all South Africans, improving
efficiency and reducing inequity. To this purpose it was decided
in the 1990s to restructure the health system, creating a decentralised
national health system and introducing a district health system.
The clinical trial industry has grown considerably over the
past years. South Africa possesses high technological medical
expertise and infrastructure, and there is a racial and cultural
diversity among the population. |
Special
feature |
| 85%
of the human genomic diversity is represented in South Africa.
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Authorities |
Department of Health
Medicines Control Council (MCC)
Medical Research Council
(MRC) |
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SOUTH
AFRICA 
