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

Mozambique reaches WHO Maturity Level 3 for medicines regulation

Mozambique’s national medicines regulatory authority, the Autoridade Nacional Reguladora de Medicamentos de Moçambique (ANARME), has been recognized by the World Health Organization (WHO) as having a stable, well-functioning and integrated regulatory system. 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. It is also the first Portuguese-speaking African country to achieve this status.

WHO evaluates national regulatory systems using its Global Benchmarking Tool (GBT), which assesses functions including registration and marketing authorization, licensing, market surveillance and control, pharmacovigilance, regulatory inspection, laboratory testing and oversight of clinical trials. WHO’s maturity levels range from 1 to 4, with ML3 indicating a stable, well-functioning and integrated system, and ML4 representing an advanced system focused on continuous improvement.

The recognition of Mozambique’s regulatory system was made following consideration and recommendation by the newly established Technical Advisory Group on Regulatory Systems Strengthening (TAG-RSS), which 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. 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. The recognition of South Africa’s ML3 status extends the recognition first granted in 2022 and underscores the sustained performance of the South African Health Products Regulatory Authority (SAHPRA).

“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.”

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.

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

AMA calls for stronger regulatory systems to boost local manufacturing

Separately, the African Medicines Agency (AMA) has called for stronger and more predictable pharmaceutical regulatory systems to support local manufacturing and advance pharmaceutical sovereignty across Africa. The call was made during a High-Level Ministerial Dialogue on regulatory systems strengthening and local pharmaceutical manufacturing held on the sidelines of the 76th session of the WHO Regional Committee for Africa.

AMA Director General, H.E. Dr Delese Mimi Darko, joined Ministers, the WHO, pharmaceutical manufacturers and development partners for discussions on strengthening regulatory systems and creating an enabling environment for local pharmaceutical production. Dr Darko stressed that establishing pharmaceutical factories alone would not be sufficient to achieve pharmaceutical sovereignty, noting that manufacturers are more likely to invest where regulatory processes are predictable and efficient.

She identified strong National Regulatory Authorities, harmonised regulatory requirements, early engagement between manufacturers and regulators, functioning quality-control laboratories and effective post-market safety systems as essential elements of a reliable pharmaceutical ecosystem.

Through its Regulatory Innovation and Manufacturing Readiness Hub, AMA is working to translate these priorities into practical support for manufacturers. The initiative helps manufacturers understand regulatory pathways at an early stage, before major investment decisions are made, with the aim of reducing avoidable regulatory delays.

Dr Darko outlined four key priorities for strengthening Africa’s pharmaceutical manufacturing ecosystem: strengthening regulatory systems, making reliance and harmonisation part of routine regulatory practice, aligning procurement policies with local manufacturing objectives, and bringing together partners to develop a predictable and quality-driven African pharmaceutical market.