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Getting the latest healthcare news for you
Getting the latest healthcare news for you
Mozambique's national medicines regulator has been recognized by the WHO as having a stable, well-functioning regulatory system, achieving Maturity Level 3 (ML3). This makes Mozambique the 10th African country to reach this milestone and the first Portuguese-speaking nation on the continent to do so. The achievement means stronger safety oversight for medicines and vaccines and greater access to quality-assured health products for Mozambicans.
Mozambique's national medicines authority, ANARME, has officially been recognized by the WHO as operating a stable, well-functioning, and integrated regulatory system — achieving Maturity Level 3 (ML3) under WHO's global classification framework. This milestone, assessed using WHO's Global Benchmarking Tool, covers key regulatory functions including product registration, pharmacovigilance, market surveillance, and laboratory testing.
For Mozambicans, this means greater assurance that medicines and vaccines on the market have been properly evaluated for quality, safety, and efficacy — and that safety concerns or substandard products can be identified and addressed more swiftly. As the first Portuguese-speaking African nation to reach ML3, Mozambique is also well-positioned to share expertise and foster regulatory cooperation across Lusophone countries and the broader continent.
By the Numbers
Why it matters: Stronger regulatory systems reduce the risk of substandard or falsified medicines reaching patients, build public trust in health products, and lay the groundwork for the newly established African Medicines Agency to advance continent-wide regulatory convergence.
