South African Health Products Regulatory Authority (SAHPRA) has become Africa’s fifth country, alongside Nigeria, Tanzania, Ghana and Egypt, to become an “ML III” (the third of four levels in the WHO’s classification) for vaccines.

Matshidiso Moeti, WHO regional director for Africa, disclosed this in a statement, noting that the designation, earned after extensive reviews by international experts and following new protocols suggested by earlier evaluations, means South Africa has achieved a WHO ranking “to ensure safety, quality and effectiveness” of vaccines it produces.

“We cannot talk about better health care without quality medical supplies. This is an important new step not only for South Africa but for the region towards self-sufficiency in vaccines and medicines,” Ms Moeti explained. “This achievement affirms South Africa’s trailblazing endeavour in health research. Beyond its technical aspects, this milestone carries real implications for people’s health. We cannot talk about better health care without quality medical supplies.”

Also, the WHO director-general, Tedros Ghebreyesus, stated that “this rapid progress on vaccines regulation is a significant milestone for South Africa, the Southern African region and the continent.”

He added, ”It is an important win for vaccine equity, as the country is a major manufacturer of medical products, and this regulatory milestone will help maximise the impact of the mRNA vaccine technology hub.”

This achievement, he said, is a testament to the role the regulator has played in ensuring that vaccines that are safe, efficacious and of high quality are available in South Africa.

(NAN)