14 Nov SAHPRA ATTAINS WHO RECOGNITION FOR ITS REGULATORY PROCESSES

The Innovative Pharmaceutical Association of South Africa (IPASA) congratulates the South African Health Products Regulatory Authority (SAHPRA) on achieving a functional level of maturity (Level 3) for its vaccine regulation, according to the World Health Organization’s (WHO’s) global classification system for national medical products regulatory authorities. Awarded in October, the recognition means that SAHPRA has a stable, well-functioning and integrated vaccine reviewing system.

The WHO’s global benchmarking tool specifies what strict systems need to be in place for overseeing the safety, efficacy and quality of health products. This is with a view to helping countries’ medicines regulators improve over time.

There are four maturity level ratings: these range from a country having some elements of a control mechanism (level one), to the regulatory system being highly developed and improving all the time (level four).

SAHPRA’s level three maturity means that all the processes aimed at ensuring people are safely immunised can be trusted to work well. This includes: bookkeeping, quality production processes, overseeing the details of how clinical trials are run, and keeping records of side effects and what caused them.

This follows SAHPRA’s systems for quality checking vaccine lots being certified to work at level four standards. Lots are large batches of products produced at the same time at a single facility before they are distributed. This recognition, which was communicated to SAHPRA by WHO at the beginning of October 2022, means SAHPRA is operating at an advanced level and continuously improving its processes in this area.

According to the WHO, having strong regulatory systems in place is part of achieving universal health coverage. This is because it reduces the chance, especially in developing countries, of people buying counterfeit, unsafe or ineffective medicines.

IPASA CEO, Bada Pharasi, wishes to commend SAHPRA on this noteworthy accolade on behalf of the association.

“SAHPRA’s success can be attributed to the tireless efforts of its employees and stakeholders in ensuring the integrity and rigour of the health products registration processes, thereby ensuring South Africans have access to safe, effective and quality health products.”