South Africa’s vaccine regulator reaches new WHO level to ensure safety, quality and effectiveness
In 2019, the South African Health Products Regulatory Authority (SAHPRA) participated in WHO-supported self-benchmarking of its regulatory system and functions
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 healthcare 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,” said Dr Matshidiso Moeti, Regional Director, Africa, WHO.
In 2019, the South African Health Products Regulatory Authority (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 regard to the vaccine 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 authorisation 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.
- Advertisement -