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 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.
