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.
The News Agency if Nigeria (NAN) reports that on March 30, the WHO announced that Nigeria’s medical products regulatory agencies had reached maturity level III,
The UN body said this means that Nigeria’s and Egypt’s regulatory agencies have been found to function well and that it could be eligible for inclusion into the transitional WHO Listed Authorities, a list that will comprise the world’s regulators of reference – that is, regulatory authorities that should be globally recognized as meeting WHO and other international standards.
NAN reports that the WHO said Egypt reached maturity level III for vaccines regulation (locally produced and imported) and Nigeria for medicines and imported vaccines.
WHO’s assessment of regulatory authorities is based on the ‘Global Benchmarking Tool.
The benchmarking of Egypt and Nigeria’s regulators was carried out by a WHO-led team of international experts.
In February and March 2022, WHO conducted a formal evaluation of the authorities and found them to perform well against most of the indicators in the Global Benchmarking Tool.
