Mozambique has reached a major milestone in strengthening the regulation of medicines and imported vaccines, with its national regulatory authority recognized by the World Health Organization (WHO) as having a stable, well-functioning and integrated regulatory system.
The Autoridade Nacional Reguladora de Medicamentos de Moçambique (ANARME) has achieved Maturity Level 3 (ML3) for the regulation of medicines and imported vaccines under WHO’s global classification of national regulatory authorities.
Mozambique becomes the 10th country in Africa to reach ML3, joining Egypt, Ethiopia, Ghana, Nigeria, Rwanda, Senegal, South Africa, Tanzania and Zimbabwe, marking further progress in strengthening regulatory systems across the continent.
For people in Mozambique, stronger regulation provides greater assurance that medicines and vaccines are appropriately evaluated for quality, safety and efficacy and monitored throughout their lifecycle. It also strengthens the country’s ability to identify and respond to safety concerns, including substandard or falsified medical products, while supporting timely access to quality-assured health products.
WHO said Mozambique’s achievement follows years of sustained efforts to build the institutions and capabilities required for effective regulation. The organization worked closely with ANARME to assess the country’s national regulatory system, identify gaps and strengthen priority areas.
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WHO evaluates national regulatory systems using its Global Benchmarking Tool, which assesses key regulatory functions including registration and marketing authorization, licensing, market surveillance and control, pharmacovigilance, regulatory inspection, laboratory testing and oversight of clinical trials, where applicable.
The WHO maturity framework ranges from Level 1 to Level 4. Reaching ML3 confirms that a country has a stable, well-functioning and integrated regulatory system, while ML4 represents an advanced system focused on continuous improvement.
The achievement could also strengthen Mozambique’s ability to cooperate with other regulatory authorities through mechanisms such as regulatory reliance. These approaches allow authorities to make use of assessments and decisions from trusted regulators, reducing unnecessary duplication and helping countries use limited resources more efficiently while maintaining standards for quality, safety and efficacy.
Mozambique is also the first Portuguese-speaking country in Africa to reach ML3. Its experience could therefore support greater knowledge sharing and regulatory cooperation among Portuguese-speaking countries and across Africa.
The development comes as efforts continue to strengthen the African regulatory ecosystem and support the work of the African Medicines Agency, which aims to advance regulatory convergence and cooperation across the continent.
WHO has also strengthened the process through which national regulatory systems are recognized. The newly established Technical Advisory Group on Regulatory Systems Strengthening (TAG-RSS) brings together independent international experts to advise WHO on whether recommendations concerning authorities reaching ML3 and ML4, as well as WHO-Listed Authorities, are supported by WHO evaluation findings.
Mozambique is among the first countries to achieve ML3 following consideration and recommendation by the TAG-RSS.As part of the same process, South Africa was recommended to retain its ML3 status for the regulation of vaccines manufactured, imported or distributed in the country following an additional WHO assessment. The recognition extends the status first granted in 2022 and reflects the continued performance of the South African Health Products Regulatory Authority.
The two recognitions highlight continued progress in strengthening regulatory systems across Africa and underline the importance of sustained performance, continuous improvement and regular assessment.
WHO said it will continue working with ANARME and the South African Health Products Regulatory Authority to sustain these gains and support further improvements as science, technology and public health needs evolve.
