SOUTH AFRICA – The World Health Organization (WHO) has issued Maturity Level Three (ML 3) status to the South African Health Products Regulatory Authority (SAHPRA) for its critical role in ensuring that available vaccines in the country are safe, efficacious and of a high quality.

SAHPRA becomes the fourth National Regulatory Authority (NRA) to become a ML3 regulatory authority in the WHO African Region alongside Tanzania, Ghana and Nigeria.

In addition, South Africa’s vaccine regulatory system 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 the mRNA vaccine technology hub located in Cape Town, South Africa,” WHO announced.

With the certification, WHO 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.

The rapid progress on vaccines regulation is also an important win for vaccine equity, as the country is a major manufacturer of medical products thus the regulatory milestone will help maximize the impact of the mRNA vaccine technology hub.

The global healthcare organization confirmed the country’s attainment of the third of four levels in the WHO’s classification while noting that maturity level four (ML4) is the highest level achieved by a regulatory system operating at an advanced level of performance and with continuous improvement.

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 Dr Matshidiso Moeti, WHO Regional Director for Africa.

She further acknowledged that the formally certification by the World Health Organization is an important new step not only for South Africa, but for the African region towards self-sufficiency in vaccines and medicines.

Dr Boitumelo Semete-Makokotlela, South African Health Products Regulatory Authority (SAHPRA) Chief Executive Officer lauded the tireless efforts of all people involved in ensuring the integrity and rigor of the country’s health products registration processes.

SAHPRA will continue to be an agile and responsive African health products regulator, whilst working towards the aim of being a globally recognized as an enabler of access to safe, effective and quality health products,” she reaffirmed.

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