WHO Ranks South Africa’s Vaccine Regulatory System at a Functional Level of Maturity

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South Africa’s vaccine regulator has reached new WHO level to ensure safety, quality, and effectiveness.

According to World Health Organization’s (WHO’s) global classification system for national medical product regulatory authorities, WHO has ranked South Africa’s vaccine regulatory system at a functional level of maturity. This ranking recognizes that South Africa has a stable, well-functioning, and integrated regulatory system to ensure the quality, safety, and effectiveness of vaccines manufactured, imported, or distributed in the country.

WHO confirmed that the country has attained maturity level three (ML3), the third of four levels in WHO’s classification system. Maturity level four (ML4) is the highest.

“This achievement affirms South Africa’s trailblazing endeavor 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 Matshidiso Moeti, WHO regional director for Africa, in a press release. “This is an important new step not only for South Africa, but for the region, toward self-sufficiency in vaccines and medicines.”


“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 maximize the impact of the mRNA [messenger RNA] vaccine technology hub,” said Tedros Adhanom Ghebreyesus, WHO director-general, in the release.

Source: WHO