26 Aug South Africa Maintains WHO Maturity Level 3 (ML3) for Vaccine Regulation
26 August 2026 – The South African Health Products Regulatory Authority (SAHPRA) is pleased to share that the World Health Organization (WHO) has confirmed that South Africa has achieved and maintained Maturity Level 3 (ML3) for the regulation of vaccines (producing), as of 18 August 2026.
South Africa first attained ML3 for vaccine regulation in 2022, placing SAHPRA among the first African regulators to achieve this status. The latest WHO re-benchmarking and subsequent review by the WHO Technical Advisory Group for Regulatory Systems Strengthening (TAG-RSS) confirms that this level of maturity has been sustained. WHO recognised significant progress across multiple regulatory functions and described the system as stable, well-functioning and integrated.
WHO’s maturity classification assesses the functionality and maturity of national regulatory authorities across areas including market surveillance, laboratory testing, regulatory inspection and marketing authorisation. ML3 reflects a regulatory system that meets internationally recognised standards and guidelines.
The continued achievement of ML3 strengthens confidence, trust and reliance on South Africa’s regulatory authority and supports the country’s health security objectives, vaccine manufacturing ambitions and contribution to the growth of the African manufacturing industry. It also positions SAHPRA to support regional regulatory strengthening, including the work of the African Medicines Agency.
This achievement reflects sustained investment in strengthening SAHPRA’s regulatory system and the contribution of industry, sister regulators and other stakeholders.
As SAHPRA celebrates the retention of ML3, the focus now turns to the quest for ML4, the highest level of regulatory maturity, through continued strengthening and improvement of regulatory systems and capabilities.
SAHPRA will continue working collaboratively with stakeholders to strengthen South Africa’s regulatory system and advance its regulatory maturity. For industry, the retained ML3 WHO GBT status provides greater regulatory predictability, strengthens confidence in SAHPRA’s decisions, supports reliance and collaboration with other regulators, and creates an enabling environment for local manufacturing, innovation and market access. For the public, it reinforces assurance that vaccines are regulated through a stable, well-functioning system that upholds standards of quality, safety and efficacy, thereby supporting timely access to trusted health products and strengthening public health security.