PSM August 2020

Boitumelo Semete-Makokotlela: Making medicine count

Chief Executive Officer of the South African Health Products RegulatoryAuthority (SAHPRA) Boitumelo Semete-Makokotlelahad a baptism by fire when she assumed office in January. She not only arrived in the last quarter of a financial year, but had to start the 2020/21 financial year dealing with a global pandemic.With experience in the health technology innovation sector and a strong research and development background, the 41-year-old has led the organisation in its efforts to strengthenSouth Africa's

coronavirus (COVID-19)response.As an entity of theNational Department ofHealth (NDOH), SAH-PRA is working with thedepartment and industryrole-players to activelymonitor the potentialimpact of the pandemic

and respond to any disruptions or medicine and medical equipment shortages. It is also playing an active role in efforts to develop a vaccine for the coronavirus disease, working alongside the NDOH and its partners, which include research institutes and health companies. With SAHPRA’s core mandate being the regulation of all health products, clinical trials, complementary medicines, medical devices and in vitro diagnostics, it contributes significantly to ensuring that the nation’s pandemic response is

properly managed. Semete-Makokotlela says SAHPRA must ensure that all health products used in the fight against COVID-19 are regulated.

Rigorous review

Before South Africa’s first COVID-19 vaccine clinical trial began at the University of the Witwatersrand in June, SAHPRA subjected it to a rigorous review process. It is SAHPRA’s duty, she emphasises, to ensure trials are within the bounds of safety, meet the required treatment standards and are done correctly.