The Department of Health will miss its April 1 deadline for establishing the South African Health Products Regulatory Agency (SAHPRA) by several months, disappointing drug companies hoping for a swift end to the delays they face in registering medicines. SAHPRA will replace the overwhelmed Medicines Control Council (MCC), which has a backlog of up to five years for registering new chemical entities, and up to almost three years for registering generic drugs, according to industry sources. The new watchdog will have a much wider mandate than the MCC, which regulates medicines and clinical trials, as it will also oversee medical devices and complementary medicines. It will be a public entity that can retain the fees it generates from applications to register products and clinical trials, and will be able to remunerate employees above public service rates, enhancing its ability to attract and retain staff. The implementation of SAHPRA has been held up by a delay in publishing its enabl...
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