THE UNITED REPUBLIC OF TANZANIA MINISTRY OF HEALTH TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY

ISO 9001: 2015: CERTIFIED

PUBLIC NOTICE

17^th October, 2025

TMDA Maintains WHO Maturity Level 3 (ML3) Status

• The TMDA is proud to announce that it has successfully maintained its Maturity Level 3 (ML3) status following a comprehensive re-benchmarking assessment conducted by the World Health Organization (WHO) in 2023.
• This is a significant and proud moment for Tanzania, as TMDA continues to demonstrate regulatory excellence, transparency, and consistent adherence to international standards in ensuring the quality, safety, and efficacy of medical products.
• TMDA made history in 2018 by becoming the first National Regulatory Authority in Africa to achieve WHO ML3 status. Maintaining this prestigious level after the 2023 re-assessment not only confirms the sustainability and robustness of TMDA’s regulatory systems, but also reinforces its leadership and pioneering role in the African region.
• The WHO Global Benchmarking Tool (GBT) is the leading framework used globally to assess and strengthen national regulatory systems. An ML3 designation signifies that TMDA functions as a stable, well-integrated, and performance-driven authority, capable of regulating medical products throughout their lifecycle—from market authorization to post-marketing surveillance and enforcement.
• This achievement is a result of dedicated teamwork, strong governance, stakeholder collaboration, and a national commitment to public health protection. It serves as a mark of confidence for Tanzanians and a benchmark for other regulatory authorities on the continent.
• TMDA extends sincere appreciation to the Government of the United Republic of Tanzania, development partners, the pharmaceutical industry, healthcare professionals, and the general public for their continued support and trust.
• As we celebrate this achievement, TMDA remains focused on continuous improvement and innovation in regulatory practices, with the long-term goal of advancing to Maturity Level 4 (ML4) — a level that represents regulatory systems operating at the highest international standards.

Issued by:
Director General,
Tanzania Medicines and Medical Devices Authority
Hombolo Road, P. O. Box 1253, Dodoma