South Africa’s Health Products Regulatory Authority (SAHPRA) has retained WHO Maturity Level 3 (ML3) for the regulation of vaccines as a producing country, confirmed as of 18 August 2026 following re-benchmarking and review by WHO’s Technical Advisory Group for Regulatory Systems Strengthening.
The producing designation is the point of commercial significance. It covers vaccines manufactured in South Africa, not only those imported, which is what underpins the country’s vaccine manufacturing ambitions and its role in African production capacity. For companies manufacturing or seeking to manufacture vaccines in South Africa, retained ML3 sustains the basis on which other regulators rely on SAHPRA decisions, and supports market access for locally produced product.
South Africa first attained ML3 for vaccine regulation in 2022, among the first African regulators to do so. WHO described the system as stable, well-functioning and integrated, and recognised progress across multiple regulatory functions. The classification assesses national regulatory authorities across functions including market surveillance, laboratory testing, regulatory inspection and marketing authorisation.
SAHPRA said the retention supports regulatory predictability for industry, reliance and collaboration with other regulators, and an enabling environment for local manufacturing and innovation, and positions the authority to support regional strengthening including the work of the African Medicines Agency. It said its focus now turns to ML4, the highest maturity level.
The confirmation came through the same TAG-RSS process under which Mozambique’s ANARME was recognised at ML3 for medicines and imported vaccines, announced by WHO on 24 August.
Source: South African Health Products Regulatory Authority, 26 August 2026 — https://www.sahpra.org.za/south-africa-maintains-who-maturity-level-3-ml3-for-vaccine-regulation/
