South African President, Jacob Zuma, recently signed the Medicines and Related Substances Amendment Bill into law. The new Act is designed to introduce amendments to the Medicines and Related Substances Act 101 of 1965. The Act creates a framework by which the current Medicines Control Council (MCC) - part of the National Department of Health - is to be replaced with the South African Health Products Regulatory Authority (SAHPRA), which will be independent of the Department of Health. The SAHPRA will employ a large number of full-time staff, including regulatory pharmacists, to assist with the evaluation of drug dossiers and the elimination of current blacklogs. Complementary and alternative products, including African Traditional Medicines, are not defined in the new Act. The Act commences upon the commencement of the Medicines and Relates Substances Amendment Act of 2008 (Act 72 of 2008), on a date to be proclaimed.
“It will have a mandate that includes management of registration and control of medicines, complementary medicines, clinical trials, active pharmaceutical ingredients, medical devices and in-vitro diagnostic medical devices Vuyo Mkize, The Star Newspaper, 15 Jan 2016