Cape Town: The World Health Organization (WHO) has awarded the South African Health Products Regulatory Authority (Sahpra) with an accolade for its vaccine regulation.
Sahpra has received a functional level maturity Level 3.
This means it has a stable well-functioning and integrated regulatory system to ensure the quality, safety and efficacy of vaccines that it registers.
WHO confirmed Sahpra’s attainment of maturity level three (ML3) for vaccine regulation — the third of four levels in the WHO’s classification. Maturity level four (ML4) is the highest level.
ML4 represents a regulatory function that is advanced, well-functioning, and continuously improving.
Sahpra said it was a noteworthy accolade as it was a fairly new independent regulatory authority.
“Sahpra and the National Control lab must be commended for reaching ML4 for the Lot Release function. This function is critical in ensuring that the vaccines made available in the country meet the highest quality requirements,” it said.
The status compares to that of the US and Singapore.
Sahpra chief executive officer Dr Boitumelo Semete-Makokotlela commended the tireless efforts of the authority’s staff members and stakeholders in ensuring the integrity and rigour of the health products registration processes.
“This achievement is a testament to the role the regulator has played in ensuring that vaccines that are safe, efficacious, and of 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,” Semete-Makokotlela said.
IOL