Oluwatobi Adu 
ABUJA, Nigeria – Mozambique, WHO medicines regulation has reached a major milestone after the country became the 10th African nation to attain the World Health Organization’s Maturity Level 3 (ML3) status for regulating medicines and imported vaccines, strengthening Africa’s ability to guarantee the quality, safety and effectiveness of medical products.
The World Health Organization announced the achievement on Monday, confirming that Mozambique’s national medicines regulatory authority, the Autoridade Nacional Reguladora de Medicamentos de Moçambique, had met the international benchmark for a stable, well-functioning and integrated regulatory system.
The recognition places Mozambique alongside Nigeria, Egypt, Ethiopia, Ghana, Rwanda, Senegal, South Africa, Tanzania and Zimbabwe as African countries with regulatory authorities capable of effectively evaluating medicines and vaccines while monitoring their safety after approval.
WHO said the development marks another step towards building stronger healthcare systems across Africa, improving public confidence in medicines and expanding access to quality-assured health products.
WHO Chief Scientist and Assistant Director-General a.i. for Health Systems, Access and Data, Dr Sylvie Briand, described the achievement as the result of years of sustained investment in regulatory capacity.
“Mozambique’s achievement is the result of sustained investment in regulatory capacity that will deliver crucial benefits for public health,” Briand said.
She added that strong regulatory systems protect people, increase confidence in medicines and vaccines, and enable countries to respond more effectively to emerging public health challenges.
“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.”
According to WHO, the milestone follows years of institutional reforms, technical assessments and capacity-building support aimed at strengthening Mozambique’s medicines regulatory authority.
As the first Portuguese-speaking African country to achieve ML3 status, Mozambique is also expected to promote closer regulatory cooperation and knowledge-sharing among Lusophone African nations while contributing to a more integrated continental medicines regulatory system.
For Nigeria, which previously attained ML3 status through the National Agency for Food and Drug Administration and Control (NAFDAC), the latest recognition underscores growing momentum towards stronger regulatory oversight across Africa.
About the Author
Oluwafunbi Bello 
Mirian Gom 