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Jan 17

South Africa is Transitioning to a New Regulator of Medicines and Medical Devices

By Nicola Main, Clinical Research Manager and Clinical Trial Operations – Rest of World Cato Research, South Africa

 

On 01 June 2017, the President of South Africa proclaimed revisions to the Medicines Act. These provide for the creation of a new regulatory authority, known as the South African Health Products Regulatory Authority (SAHPRA). This new regulator will be responsible for the evaluation and registration of medicines (including complimentary medicines), as well as medical devices and in-vitro diagnostics. The Authority will also ensure that clinical trial protocols are being assessed according to prescribed ethical and professional criteria and defined standards.

 

A government notice requesting nominations for the Board of SAHPRA was published on 06 June 2017 and on 09 October 2017 the Minister of Health published the names of the 15 members of the Board. (The Minister of Health appoints the Board members of SAHPRA, and SAHPRA acts through its Board.) The Board have been appointed for a 3 year term of office, expiring on 30 September 2020.

 

Although the Board has been appointed, a number of items need to take place before the SAHPRA formally take over from the current regulator, the Medicines Control Council (MCC). Some of these are described in Section 26 (Transitional Arrangements) of Act 14 of 2015 (which also came into operation when Act 72 of 2008 was proclaimed) and include the transition of staff, movable property and pending registration applications. In addition to these Transitional Arrangements, another key step is for the Treasury to formally approve SAHPRA as a Section 3a Public Entity. so that it can retain revenue*.

 

As SAHPRA will have the power to retain the registration and clinical trials application fees, as well as other fees, it generates and is allowed to remunerate staff at rates higher than those typically paid in the public service, it is expected that this will enhance its ability to attract and retain staff. The State, through the Department of Health, is expected to fund SAHPRA initially but the Authority is ultimately expected to secure 70% of its budget from fees.

 

The MCC will continue to exist and carry out its functions until the day before the first meeting of the SAHPRA. This meeting will be on a date determined by the Minister of Health but is largely expected to be in the first quarter of 2018. As described in the Transitional Arrangements, all previous decisions, guidelines and procedures that are within the scope of the SAHPRA’s functions, and which are in force on the day of the first Board meeting date will remain in force until they are amended or repealed by the SAHPRA.

 

*A Section 3A Public Entity (or national government business enterprise) is normally an extension of a public entity with the mandate to fulfil a specific economic or social responsibility of government. It relies on government funding and public money. Examples are the South African Revenue Service, South African National Parks and National Health Laboratory Service.