The Tanzania Medicines and Medical Devices Authority (TMDA) has retained its prestigious World Health Organization (WHO) Maturity Level 3 (ML3) status for its medicines and vaccines regulatory system reaffirming the country’s global leadership in ensuring the safety, quality, and effectiveness of health products.
In a public statement, TMDA said the reaffirmation follows a comprehensive reassessment conducted by WHO in 2023.
The outcome confirms that Tanzania continues to meet rigorous international standards in regulating pharmaceuticals and medical devices.
This latest recognition marks another milestone for TMDA, which in 2018 made history by becoming the first health regulatory authority in Africa to attain WHO Maturity Level 3.
The renewed status demonstrates that the Authority’s systems remain strong, transparent, and reliable in protecting public health.
According to TMDA, maintaining WHO ML3 status means Tanzanians can trust that the medicines and vaccines they use are of high quality, safe, and effective.
It also ensures stronger protection against counterfeit and substandard drugs and boosts national preparedness for public health emergencies such as disease outbreaks.
Beyond safeguarding health, the achievement places Tanzania in a stronger position internationally. It enhances opportunities for the country to participate in joint regulatory initiatives, expand access to regional and global markets, and attract new investment into the pharmaceutical and medical device sectors.
TMDA described the recognition as a collective national success, applauding development partners, healthcare professionals, and Tanzanians at large for their continued cooperation and commitment to improving public health.


