The South African Health Products Regulatory Authority (SAHPRA) has been recognised as a stable, well-functioning and integrated regulatory body to ensure the quality, safety and effectiveness of vaccines manufactured, imported or distributed in the country.
The World Health Organisation (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 means that SAHPRA has a stable, well-functioning and integrated regulatory system to ensure the quality, safety, and efficacy of vaccines that are registered by SAHPRA,” SAHPRA explained.
According to a statement released on Wednesday, WHO confirmed the country’s attainment of maturity level three (ML3) — the third of four levels in WHO classification, with maturity level four (ML4) the highest.
As a fairly new, independent regulatory authority, SAHPRA said this is indeed a noteworthy accolade.
In addition, SAHPRA and the National Control Lab reached ML4 for the lot release function, a critical task in ensuring that the vaccines made available in the country meet the highest quality requirements.
ML4, according to SAHPRA, represents a regulatory function that is advanced, well functioning and continuously improving.
According to the statement, this status compares to that of the United States and Singapore, as examples.
SAHPRA CEO, Dr Boitumelo Semete-Makokotlela, has since commended the tireless efforts of staff members and stakeholders 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 regulator and an enabler of access to safe, effective and quality health products,” she said.
WHO Regional Director for Africa, Dr Matshidiso Moeti, said: “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.”
She said this was an important new step not only for South Africa but also for the region towards self-sufficiency in vaccines and medicines.
Meanwhile, WHO Director-General, Dr Tedros Adhanom Ghebreyesus, said this rapid progress in 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.” – SAnews.gov.za
