Mozambique’s medicines and vaccines regulator has been recognised by the World Health Organisation as meeting Maturity Level 3, a milestone that confirms the country has a stable and well‑functioning regulatory system for medicines and imported vaccines.
WHO said on Wednesday that the National Drug Regulatory Authority of Mozambique (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’s achievement is the result of sustained investment in regulatory capacity that will deliver crucial benefits for public health,” WHO chief scientist Sylvie Briand said.
She noted that strong regulatory systems such as the one in Mozambique “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.”
The recognition makes Mozambique the 10th African country to reach Maturity Level 3 under WHO’s global framework, joining Egypt, Ethiopia, Ghana, Nigeria, Rwanda, Senegal, South Africa, Tanzania and Zimbabwe.
It is the first Portuguese‑speaking regulator in Africa to achieve this level, strengthening opportunities for regional cooperation and knowledge sharing.
The UN agency’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.
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.
JN/APA