Unlike with medicines, and with a few exceptions, South Africa’s regulator does not assess whether diagnostic tests and other medical devices on the market are safe and work as they are supposed to. The regulator has however started down a road that should eventually lead to the regulation of all medical devices in the country. Catherine Tomlinson unpacks the details.
The South African Health Products Regulatory Authority has often made the headlines in recent years – be it in relation to COVID-19 vaccines, access to ivermectin, the approval of an HIV prevention injection, or most recently the clearing of inherited backlogs. Catherine Tomlinson assesses the state of South Africa’s medicines regulator as 2022 draws to a close.
As a rebellious teenager growing up in the British town of Harpenden, Professor Helen Rees would sneak out to attend anti-apartheid talks. Today, she is a renowned scientist and chair of South Africa’s medicines regulator. Biénne Huisman chatted to Rees about her career, prioritising women’s reproductive health, and her role at the South African Health Products Regulatory Authority.
Recently the South African Health Products Regulatory Authority was criticised for not approving laboratory-based SARS-CoV-2 antibody tests. Spotlight Editor Marcus Low argues that despite the regulator’s capacity constraints, its flexible conservatism is something to be grateful for.
Delays at the South African National AIDS Council (SANAC) has meant that the new NSP (National Strategic Plan) will now only be ready in March 2017.
By Anso Thom and Marcus Low – The Medicines Control Council (MCC) this week suspended what appears to be unlawful stem cell experimentation at Pelonomi, a state hospital in Bloemfontein.
