SAHPRA streamlines approval process for vaccines
Dr Semete-Makokotlela, CEO of the SA Health Products Regulatory Authority (SAHPRA), announced that SAHPRA - as well as other regulators - have agreed on the minimum requirements for the various countries to speed up the processes of reviewing Covid-19 vaccines.
A specialised working group called the Covid-19 Vaccine Registration Working Group, has been established to manage the process. The group include external and internal SAHPRA experts in areas of virology, vaccinology, manufacturing, clinical trials, epidemiology, vigilance and other specialisations informing the quality, safety and efficacy of Covid-19 vaccines.
SAHPRA has also published various Covid-19 vaccine guideline documents to guide applicants on the process and requirements for vaccine authorisation.