South African Health Products Regulatory Authority (SAHPRA)

1 March 2018

With effect from June 1, 2017, the national medicines regulatory authority is titled South African Health Products Regulatory Authority (SAHPRA).  SAHPRA replaces the MCC (Medicines Control Council). 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.

SAHPRA acts through its Board and will be led by its Chief Executive Officer and Vice Chief Executive Officer, who will both be appointed by the Minister of Health from the members of the Board. The Minister of Health, Dr Aaron Motsoaledi, has appointed members of the SAHPRA board.

SAHPRA ensures the quality, safety and efficacy of medicines, medical devices and IVDs (in vitro diagnostic) and is responsible to provide for the monitoring, evaluation, regulation, investigation, inspection, registration and control of medicines, scheduled substances, clinical trials and medical devices, IVDs and related matters in the public interest.

With SAHPRA the regulator’s human resource capacity will be improved.  Provisions are in place to allow mutual recognition agreements between SAHPRA and other international regulatory authorities such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) which are expected to translate into improved efficiencies.