South African Health Products Regulatory Authority ranked at maturity level 3 out of 4 classification levels
South Africa's shift to ML3 will significantly help low and middle income countries with mRNA vaccines. Photo for representation: Wikimedia Commons South Africa’s vaccine regulatory system received the World Health Organization approval September 5, 2022.
South African Health Products Regulatory Authority (SAHPRA) is the national regulatory authority to ensure medical products’ safety, quality and efficacy.
WHO ranked the regulatory system at maturity level 3 (ML3) — the third of four levels in its global classification system for national medical products regulatory authorities.
The designation ML3 confirms a stable, well-functioning and integrated regulatory system is in place. Quality medical supplies are an important aspect of a good healthcare system.
The highest level, ML4, is achieved by a regulatory system operating at an advanced level of performance and with continuous improvement.
“This achievement affirms South Africa’s trailblazing endeavour in health research,” said Matshidiso Moeti, WHO regional director for Africa.
In 2019, SAHPRA participated in the self-benchmarking of its regulatory system and functions. It further enhanced this self-benchmarking in 2021 with WHO assistance, said a press release by the global health body.
Read more: Why we must celebrate India’s indigenous HPV vaccine
WHO completed its benchmarking of SAHPRA in November 2021. The regulatory body was required to address several gaps with regard to vaccine regulation as recommended by a team of 19 international experts from 10 countries.
It made major progress in several areas, including staffing, quality management and regulatory presence at ports of entry between November 2021 and August 2022.
“SAHPRA will continue to be an agile and responsive African health products regulator,” said Boitumelo Semete-Makokotlela, SAHPRA chief executive officer.
It is the fourth national regulatory authority to get the ML3 approval for vaccines in the WHO African Region. SAHPRA is also the fifth to achieve this status in the African continent, besides Egypt, which earned ML3 for vaccines earlier in 2022.
The shift to ML3 will significantly contribute to WHO work to help low- and middle-income countries to build capacity for producing mRNA vaccines.
We are a voice to you; you have been a support to us. Together we build journalism that is independent, credible and fearless. You can further help us by making a donation. This will mean a lot for our ability to bring you news, perspectives and analysis from the ground so that we can make change together.
.png)
Comments are moderated and will be published only after the site moderator’s approval. Please use a genuine email ID and provide your name. Selected comments may also be used in the ‘Letters’ section of the Down To Earth print edition.