We are very much familiar with the HA’s abbreviations, MCC is one of them. Now officially its no longer in use for South African agency, with recent announcement of Ministry of Health, South Africa; appointment of SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY (SAHPRA) BOARD.
SAHPRA replaces the Medicines Control Council (MCC). The scope of the new Authority has expanded to include not only medicines, but also medical devices including in-vitro diagnostics, and aspects of radiation control. We have seen swift drift in Medical devices regulation, both from US FDA and EMA. Now SAHPRA contributed to it by making it their one of the main objective. It was conceptualized in early 2017, with registration of medical devices companies.
SAHPRA will be responsible for monitoring, evaluation, regulation, investigation, inspection, registration and control of medicines, scheduled substances, clinical trials, medical devices and related matters in the public interest. All OUTSTANDING WORKthat was being done by the MCC will be continued by SAHPRA. The Authority will utilize external experts for evaluation of applications, but over time it will actively grow the in-house capacity of the staff to take over the bulk of its work including registration of medicines and evaluations for clinical trials.