Mozambique Reaches Major Milestone in Medicine and Vaccine Safety

For Mozambique, reaching ML3 could make regulatory decisions more timely and predictable while giving health authorities stronger tools for safety monitoring.

Mozambique has taken an important step in protecting people from unsafe or poor-quality health products after its national medicines regulator reached Maturity Level 3 (ML3). World Health Organization recognition shows that the country now has a stable, well-functioning and integrated system for regulating medicines and imported vaccines. The recognition places Mozambique among a growing group of African countries that have built stronger systems for checking whether medical products are safe, effective and of suitable quality before and after they reach patients.

The Autoridade Nacional Reguladora de Medicamentos de Moçambique (ANARME) achieved ML3 under WHO's global classification of national regulatory authorities, making Mozambique the 10th African country to reach this level. It joins Egypt, Ethiopia, Ghana, Nigeria, Rwanda, Senegal, South Africa, Tanzania and Zimbabwe, while becoming the first Portuguese-speaking African country to secure the recognition.

Stronger checks offer greater protection for patients

For people who depend on medicines and vaccines, the milestone has practical significance because a stronger regulator can evaluate products before they enter the market, monitor their safety once they are being used and respond when problems emerge. This includes identifying substandard or falsified medical products, investigating safety concerns and making sure medicines and imported vaccines continue to meet appropriate requirements throughout their lifecycle.

WHO Chief Scientist and Assistant Director-General a.i. for Health Systems, Access and Data Dr Sylvie Briand described the achievement as the result of sustained investment in regulatory capacity, noting that effective regulation protects public health, strengthens confidence in medical products and gives countries greater ability to respond to changing health needs.

Mozambique reached this stage after years of work to strengthen the institutions, expertise and regulatory functions managed by ANARME. WHO worked with the authority during the process, assessing the national system, identifying gaps and supporting improvements in areas considered essential for effective oversight.

What Maturity Level 3 means for Mozambique

National regulatory systems are evaluated through WHO's Global Benchmarking Tool, which examines the functions needed to oversee medical products effectively. The assessment covers areas such as product registration and marketing authorization, licensing, market surveillance, pharmacovigilance, regulatory inspections, laboratory testing and oversight of clinical trials where applicable.

The maturity scale runs from Level 1 to Level 4. ML3 shows that a country has established a regulatory system that functions consistently and operates in an integrated way, while ML4 represents an advanced system with a strong focus on continuous improvement.

For Mozambique, reaching ML3 could make regulatory decisions more timely and predictable while giving health authorities stronger tools for safety monitoring. A capable national regulator can also make better use of assessments and decisions made by trusted regulatory authorities elsewhere, reducing unnecessary duplication and allowing limited technical resources to be directed toward areas where they are most needed without lowering safety or quality standards.

Mozambique's progress could support cooperation across Africa

The milestone carries importance beyond Mozambique's borders. As Africa's first Portuguese-speaking country to achieve ML3, Mozambique can share its experience with other Portuguese-speaking nations working to strengthen their own regulatory institutions, while closer cooperation between African regulators can support knowledge sharing, regulatory reliance and more efficient access to quality-assured health products.

This growing network of capable national authorities also provides a stronger base for the newly established African Medicines Agency, which is expected to support regulatory convergence and cooperation across the continent. More aligned regulatory systems can help countries use expertise more efficiently while maintaining rigorous scrutiny of medicines and vaccines reaching African communities.

Independent review strengthens confidence in recognition

Mozambique is also among the first countries to achieve ML3 after consideration by WHO's newly established Technical Advisory Group on Regulatory Systems Strengthening, known as TAG-RSS. The group brings together independent international experts who review whether recommendations for ML3, ML4 and WHO-Listed Authority recognition are supported by WHO evaluation findings, adding another layer of independent scrutiny to the process.

South Africa was considered through the same process and recommended to retain its ML3 status for vaccines manufactured, imported or distributed in the country following an additional WHO assessment. The decision extends the recognition originally granted in 2022 and reflects continued regulatory performance by the South African Health Products Regulatory Authority.

Mozambique's recognition shows how sustained investment in regulatory institutions can translate into stronger safeguards for patients while contributing to a more connected African medicines regulatory system. Continued assessment and improvement will remain important as new medicines, vaccines, technologies and public health challenges emerge, with WHO expected to continue supporting ANARME and South Africa's SAHPRA in maintaining and strengthening their regulatory capabilities.