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South Africa’s Vaccine Regulation System Earns WHO Endorsement, Says Official


(AFRICAN EXAMINER) – 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.

Dr Matshidiso Moeti, WHO Regional Director for Africa made this known in a statement issued by the world health body.

Moeti said 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.”

“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,” said Moeti.



Also, the WHO Director-General, Dr Tedros Ghebreyesus, said:” this rapid progress on vaccines regulation is a significant milestone for South Africa, the Southern African region and the continent.

”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.”

Ghebreyesus commended the tireless efforts of all those involved in ensuring the integrity and rigour of the health products registration processes.

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


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