WHO gives maturity level three to SAHPRA for vaccine regulation Picture: AFP
The South African Health Products Regulatory Authority (Sahpra) has been ranked by the World Health Organization (WHO) at a functional level of maturity – Level 3 – 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 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.
Sahpra chief executive Dr Boitumelo Semete-Makokotlela commended the efforts of their staff members and stakeholders in ensuring the integrity and rigour of the health products registration processes.
Semete-Makokotlela said the achievement was testament to the role the regulator played in ensuring that vaccines that were safe, efficacious and of a high quality were available in South Africa.
“Sahpra will continue to be an agile and responsive African health products regulator, while working towards the aim of being a globally recognised regulator and an enabler of access to safe, effective and quality health products.”
She said as a fairly new instituted independent regulatory authority, this was a noteworthy accolade for Sahpra.
Sahpra and the National Control Lab were 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. ML4 represents a regulatory function that is advanced, well-functioning and is continuously improving. To put in context, this status compares to that of the US and Singapore as examples,” Sahpra said.
Cape Times
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