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South African Report Questions Benefit of Proposed Authority

January 16, 2009
A proposed regulatory body responsible for both drugs and medical devices may not be worth the additional resources required to support it, the South African Department of Health says. Legislation was introduced last year to replace the Medicines Control Council with a new South Africa Health Product Regulatory Authority. According to a new report from the Department of Health, reaction to the bill has been “vociferous” with critics charging that, if enacted, it would undermine scientific oversight of health products and clinical trials regulation in South Africa.
International Medical Device Regulatory Monitor