Mozambique has strengthened its national health protection system after the World Health Organization (WHO) recognized the country’s medicines and vaccine regulatory authority as having a stable and well-functioning system.

The Autoridade Nacional Reguladora de Medicamentos de Moçambique (ANARME) has achieved Maturity Level 3 (ML3) under WHO’s global classification of national regulatory authorities. Mozambique is the 10th African country to reach this level, joining countries including Egypt, Ethiopia, Ghana, Nigeria, Rwanda, Senegal, South Africa, Tanzania and Zimbabwe.

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The achievement reflects years of efforts to improve regulatory capacity, including product registration, market surveillance, pharmacovigilance, inspections, laboratory testing and clinical trial oversight.

“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.”

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For patients, stronger regulation can provide greater confidence that medicines and vaccines meet standards for quality, safety and efficacy. It also strengthens the country’s ability to identify safety concerns and respond to substandard or falsified medical products.

As the first Portuguese-speaking country in Africa to reach ML3, Mozambique’s progress could also support greater regulatory cooperation and knowledge sharing across the continent.