South Africa’s Vaccine Regulator Reaches New WHO Level to Ensure Safety, Quality And Effectiveness

Geneva — WHO has ranked South Africa’s vaccine regulatory system at a functional level of maturity, according to WHO’s global classification system for national medical products regulatory authorities. This recognises 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 the country’s attainment of maturity level three (ML3)—the third of four levels in the WHO’s classification. Maturity level four (ML4) is the highest.

“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 Dr Matshidiso Moeti, WHO Regional Director for Africa. “This is an important new step not only for South Africa, but for the region towards 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 maximise the impact of the mRNA vaccine technology hub.” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General.

“We commend the tireless efforts of all those involved in ensuring the integrity and rigour of the health products registration processes. This achievement 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. SAHPRA will continue to be an agile and responsive African health products regulator, whilst working towards the aim of being a globally recognised as an enabler of access to safe, effective and quality health products” said Dr Boitumelo Semete-Makokotlela, South African Health Products Regulatory Authority (SAHPRA) Chief Executive Officer.

In 2019, SAHPRA participated in WHO-supported self-benchmarking of its regulatory system and functions. Between July and August 2021, SAHPRA further refined and enhanced this self-benchmarking with WHO assistance.

In November 2021, WHO completed its benchmarking of SAHPRA, with a team of 19 international experts from 10 countries, which concluded that SAHPRA was required to address several gaps with regards to vaccines regulation. Recommendations were provided in the form of an Institutional Development Plan (IDP) for SAHPRA.

Between November 2021 and August 2022, SAHPRA made major progress in several areas including: staffing, quality management, establishing a framework for renewal of marketing authorization of medical products, and regulatory presence at ports of entry.

In September 2022, a subsequent WHO formal benchmarking mission concluded that SAHPRA had achieved ML3 for vaccines regulation.

SAHPRA is the fourth National Regulatory Authority (NRA) to become a ML3 regulatory authority for vaccines in the WHO African Region alongside Tanzania, Ghana and Nigeria. It is the fifth to achieve this status in the African continent, following Egypt which achieved ML3 for vaccines earlier in 2022. This move to ML3 will significantly contribute to WHO work to build capacity in low- and middle-income countries to produce mRNA vaccines through a centre of excellence and training (the mRNA vaccine technology hub) located in Cape Town, South Africa.
Notes to editors

Results of the global benchmarking evaluation are presented as maturity levels on a scale of 1 to 4. Achieving Maturity Level 1 means some elements of a regulatory system exist. Maturity Level 2 indicates an evolving national regulatory system that partially performs essential regulatory functions. More information is available here.

South Africa’s vaccine regulator reaching a new WHO rank to ensure safety, quality & effectiveness. The designation Maturity Level 3 confirms a stable, well-functioning and integrated regulatory system is in place. The highest level, Maturity Level 4, is achieved by a regulatory system operating at an advanced level of performance and with continuous improvement.

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