|Physical Address:||Civitas Building, 42 Andries Street, Pretoria, South Africa|
|Postal Address:||Private Bag X828, Pretoria, 0001, South Africa|
|Phone:||+27 (0)12 395 8000|
|Fax:||+27 (0)12 395 8468|
The Medicines Control Council (MCC) is a statutory body that regulates the performance of clinical trials and registration of medicines and medical devices for use in specific diseases. The MCC is responsible to ensure that all clinical trials of both non-registered medicines and new indications of registered medicines comply with the necessary requirements for safety, quality and efficacy.
Applications for clinical trials and for registration of medicines and medical devices are reviewed by an MCC expert committee, which considers amongst other issues the scientific, medical and ethical issues of the applications. Reports on the progress of the study are sent to the MCC on a regular basis. Proof of safety, quality and efficacy must be submitted when applying to the MCC for approval and registration of a medicine for use in South Africa.
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