Mozambique’s national medicines regulator has been recognised by the World Health Organization as operating a stable, well-functioning and integrated regulatory system, reaching Maturity Level 3 (ML3) for the regulation of medicines and imported vaccines.
For companies registering products in Mozambique, the practical consequence is reliance. An ML3 authority can make greater use of decisions taken by other trusted regulators, which should mean more predictable timelines and less duplication in registration and inspection — and it positions the Autoridade Nacional Reguladora de Medicamentos (ANARME) as a partner in regional work-sharing rather than a standalone reviewer.
Mozambique is the tenth African country to reach ML3, joining Egypt, Ethiopia, Ghana, Nigeria, Rwanda, Senegal, South Africa, Tanzania and Zimbabwe, and the first Portuguese-speaking African country to do so.
“Mozambique’s achievement is the result of sustained investment in regulatory capacity that will deliver crucial benefits for public health,” said Dr Sylvie Briand, WHO chief scientist and assistant director-general a.i. for health systems, access and data. “Strong regulatory systems protect people, build confidence in health products and help countries respond more effectively to evolving public health needs and challenges.”
WHO assesses regulatory systems using its Global Benchmarking Tool, covering registration and marketing authorisation, licensing, market surveillance and control, pharmacovigilance, regulatory inspection, laboratory testing and clinical trial oversight. Maturity levels run from 1 to 4; ML3 denotes a stable, well-functioning and integrated system, while ML4 denotes an advanced system focused on continuous improvement.
Mozambique is among the first countries recognised following consideration by the newly established Technical Advisory Group on Regulatory Systems Strengthening (TAG-RSS), a body of independent experts that advises WHO on whether ML3, ML4 and WHO-Listed Authority recommendations are supported by evaluation findings.
Under the same process, South Africa was recommended to retain ML3 for the regulation of vaccines manufactured, imported or distributed in the country, extending recognition first granted to the South African Health Products Regulatory Authority in 2022.
WHO said the recognition provides a foundation for the newly established African Medicines Agency to build on in advancing regulatory convergence, and that it would continue working with both authorities to sustain the gains.
Source: World Health Organization, 24 August 2026 — https://www.who.int/news/item/24-08-2026-mozambique-strengthens-regulation-of-medicines-and-imported-vaccines–boosting-health-protection
