The Minister of Health has appointed the board members of the newly established South African Health Products Regulatory Authority (SAHPRA). This health agency is the successor to the Medicines Control Council (MCC) which for decades has been the only medicines regulator in South Africa. A well-resourced and streamlined regulator is seen as the first step towards realising improved turnaround times on new registration applications, which will benefit the public and healthcare economy.

SAHPRA has a wider mandate than its predecessor in that, in addition to medicines, it will also regulate medical devices and complementary medicines. The regulator plays a pivotal role in ensuring efficient, effective and ethical evaluation and registration of medicines, medical devices, in vitro diagnostic devices, and clinical trials involving these products.

It is widely hoped that the long-awaited transition from the MCC to SAHPRA will lead to greater efficiency in registration times and processes, with the result that approval times for new medicines and medical devices will be reduced. A significant registration backlog currently exists, with reported approval times of up to five years for new medicines.

The Board appointments have been made in terms of the Medicines and Related Substances Amendment Act 2015 which recently became operative and which introduced the statutory mechanisms necessary for SAHPRA to begin operating. The 15 Board members have diverse skills and expertise in various categories of appointment such as medicine, good manufacturing practice, governance and human resource management.

The newly appointed SAHPRA Board will serve an initial three-year term ending on 30 September 2020. See the list of appointed members in the Government Gazette.

For a discussion of your organisation’s particular requirements in relation to medicines and medical devices regulation under the revised laws, please contact any member of the South African Life Sciences and Healthcare team.