Mozambique Strengthens Regulation of Medicines and Imported Vaccines
Tuesday, August 25, 2026
Mozambique has reached a major milestone in strengthening the regulation of medicines and imported vaccines, with its national regulatory authority recognised by the 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. Contd
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.”
