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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.
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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.
Without high-quality medical supplies, we cannot discuss better healthcare, said Moeti.
Additionally, the WHO Director-General, Dr. Tedros Ghebreyesus, stated that South Africa, the Southern African area, and the continent have reached an important milestone with the swift development in vaccine regulation.
The fact that the nation is a large producer of medical products and that this regulatory accomplishment will assist maximize the impact of the mRNA vaccine technology hub make it a significant victory for vaccine equity.
Ghebreyesus applauded the diligent efforts of everyone concerned with upholding the honesty and accuracy of the procedures for registering health items.
This accomplishment, he claimed, is evidence of the part the regulator has played in ensuring that vaccinations of a high standard are available in South Africa.
The WHO stated on March 30 that Nigeria’s medicinal product regulatory agencies have attained maturity level III, according to the News Agency of Nigeria (NAN).
According to the UN organization, this indicates that the regulatory agencies in Nigeria and Egypt are in good working order and may be eligible for inclusion in the temporary WHO Listed Authorities, a list that will include the world’s regulators of reference, or regulatory authorities that should be widely acknowledged as meeting WHO and other international standards.
According to Cezzatech, the WHO has rated Egypt and Nigeria as having reached maturity level III for the regulation of vaccines (both domestically produced and imported).
The “Global Benchmarking Tool” is the foundation for WHO’s evaluation of regulatory agencies.
A team of international specialists under the direction of the WHO benchmarked the regulatory systems in Egypt and Nigeria.
The WHO evaluated the authorities formally in February and March 2022 and discovered that they performed admirably for the majority of the indicators in the Global Benchmarking Tool.
