Mozambique strengthens regulation of medicines and imported vaccines, boosting health protection

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 and marking further momentum in strengthening regulatory systems across the region.

For people in Mozambique, stronger regulation means 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 and substandard or falsified products, while supporting timely access to quality-assured health products.

"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. Mozambique's progress also contributes to advancing regulatory capacity across Africa and promoting more equitable access to safe and quality-assured medicines and vaccines."

Building a stronger regulatory system

Mozambique's achievement follows years of sustained efforts to build the institutions and capabilities needed for effective regulation.

WHO worked closely with ANARME throughout this process, assessing the national regulatory system and supporting the authority in addressing identified gaps and strengthening priority areas.

WHO evaluates national regulatory systems using its Global Benchmarking Tool (GBT), which assesses the regulatory functions required to ensure the quality, safety and efficacy of medical products. These include registration and marketing authorization, licensing, market surveillance and control, pharmacovigilance, regulatory inspection, laboratory testing and oversight of clinical trials, as applicable.

WHO's maturity levels range from 1 to 4. Reaching ML3 confirms a stable, well-functioning and integrated regulatory system, while ML4 represents an advanced system focused on continuous improvement.

Benefits for Mozambique and the African continent

An ML3 regulatory system can support more timely and predictable regulatory decisions, reinforce safety monitoring and help ensure that health products entering and remaining on the market meet appropriate standards.

It also creates greater opportunities for regulatory cooperation and reliance - approaches that help authorities make use of the work and decisions of trusted regulators, reduce unnecessary duplication and allocate limited resources more efficiently, while maintaining rigorous standards for quality, safety and efficacy.

As the first Portuguese-speaking country in Africa to reach ML3, Mozambique's experience can also contribute to strengthening regulatory systems and fostering greater cooperation, knowledge sharing and reliance among Portuguese-speaking countries and across the African continent. Its achievement further reinforces a more connected African regulatory ecosystem, providing a solid foundation on which the newly established African Medicines Agency can build to advance regulatory convergence and cooperation across the region.

Strengthening confidence in regulatory recognition

Mozambique's achievement comes as WHO strengthens the process through which the performance of national regulatory systems is 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 regulatory authorities reaching ML3 and ML4 and WHO-Listed Authorities, are supported by the findings of WHO evaluation processes. Its recommendations provide an additional level of independent assurance, strengthening the impartiality, transparency and credibility of WHO's recognition process.

Mozambique is among the first countries to achieve ML3 following consideration and recommendation by the TAG-RSS.

As part of the same TAG-RSS 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. This extends the recognition first granted in 2022 and underscores the sustained performance of the South African Health Products Regulatory Authority (SAHPRA).

The two recognitions highlight continued progress in strengthening regulatory systems across Africa, as well as the importance of continued performance, improvement and assessment in sustaining regulatory maturity.

WHO will continue working with ANARME and SAHPRA to sustain these gains and support continuous improvement as science, technologies and public health needs evolve.