Medicines Control Council (MCC) & 9/10/2018 Medicines Control Council (MCC) & update on SA Health Products Regulatory Authority Portfolio Committee of Science and Technology 31 August 2016

1. OVERVIEW OF THE ACT The Act will create the South African Health Products Regulatory Authority (SAHPRA), which will replace the existing Medicines Control Council (MCC). The scope of the proposed assignment of functions to SAHPRA as a new public entity is wide and comprehensive and considerably more than the current. The new national medicines regulatory authority will have a mandate that will include management of the registration, regulation and control of medicines, complementary medicines, clinical trials, active pharmaceutical ingredients, medical devices and in vitro diagnostic (IVD) devices. Intended to strengthen drug regulatory capacity especially for inspection, quality control and laboratory work.

2. WHY THE CURRENT AMENDMENT To strengthen the governance of the proposed South African Health Products Regulatory Authority (SAHPRA), as a Schedule 3A Public Entity. To provide for the establishment of a Board. To provide for the functioning of SAHPRA under the Board. To define functions & responsibilities of the Board. To include provisions that enable the recognition of work done by selected regulators in order to reduce duplication of effort in the statute.

3. WHAT OF SAHPRA? SAHPRA will be a Schedule 3A public entity with operational autonomy, accountability and with responsibility for regulation of all medicines, medical devices and in vitro diagnostics, and for radiation control. This includes the inspection and compliance functions. Currently the MRA/ MCC focuses on the regulation of medicine only and therefore SAHPRA is a completely different entity in terms of function and size. SAHPRA will be accountable to the Minister of Health through a Board. Statutory Advisory Committees will oversee each major function of SAHPRA and a Chief Executive Officer will manage the Authority. SAHPRA as a public entity (PE) will be at an arm's length from its parent ministry but will in effect be an extension of the Department of Health with the mandate to fulfil a specific responsibility of Government to regulate medicines and medical devices.

3. SCOPE OF REGULATIONS The Regulations borne of the Medicines Amendment Act (Act 14 of 2015) include but not limited to the following: Registration and regulation of medicines. Licensing manufacturers, wholesalers and distributors. Regulation of medical devices and in vitro diagnostics, Complementary and Alternative medicines and blood derived products. Scheduling of medicines in accordance with the substances contained in the medicines.