As the Covid-19 pandemic continues, scientists everywhere are working to develop a vaccine that will prevent people from contracting the disease.Africa Check has debunked many false claims suggesting that a “cure” or vaccine for the disease already exists. Many such claims are false. Others involve potential treatments that have not been shown to work.
So what standards would a Covid-19 vaccine – or any medical product – have to meet in order to be approved for use in South Africa? And how long does approval take? This factsheet answers these and other frequently asked questions.
Who approves medicines in South Africa?
The South African Health Products Regulatory Agency (Sahpra) regulates all medical products in the country under the Medicines and Related Substances Act.
Safura Abdool Karim is a senior researcher and public health lawyer at the Wits University School of Public Health and the South African Medical Research Council’s Centre for Health Economics and Decision Science, both in Johannesburg. She also works at Priceless SA, a research group which focuses on improving health in South Africa.
“If you want to sell a product in South Africa, you need it to be registered with Sahpra” she said. Without Sahpra registration, a health product cannot be prescribed, sold or even advertised.
The agency itself does not run safety trials. Instead, it approves trials designed by drug manufacturers, to ensure they are run fairly, and reviews the results afterwards.
*The views of the above article are those of the author and do not necessarily reflect the views of Africa Speaks 4 Africa or its editorial team.