By EMMANUEL MASSAKA
TANZANIA has achieved another milestone in its ongoing commitment to protecting public health after the Tanzania Medicines and Medical Devices Authority (TMDA) successfully retained its World Health Organization (WHO) Maturity Level 3 (ML3) status, following a rigorous re-benchmarking assessment conducted in 2023.
The development is being hailed as a major victory for national health security, reaffirming Tanzania’s ability to ensure that all medicines, vaccines, and medical devices circulating in the market are safe, effective, and of assured quality.
TMDA first made history in 2018, when it became the first National Regulatory Authority in Africa to achieve the WHO ML3 ranking.
Retaining this global recognition after the 2023 reassessment underscores Tanzania’s continued regulatory excellence and its strong institutional capacity to safeguard the health of its citizens.
“This is a proud moment for our nation,” said the TMDA Director General, Dr Adam Fimbo in a statement released yesterday.
“Maintaining WHO Maturity Level 3 status demonstrates that Tanzania’s regulatory systems are robust, transparent, and reliable. Above all, it means Tanzanians can continue to have full confidence in the safety and quality of the medical products they use every day,” he said.
The WHO’s Global Benchmarking Tool (GBT) is the leading international framework for evaluating national regulatory systems.
Dr Fimbo said that an ML3 designation signifies that TMDA functions as a stable, well-integrated, and performance-driven authority, capable of overseeing the entire lifecycle of medical products, from market authorization and manufacturing to post-market surveillance and enforcement.
Experts say this achievement has far-reaching implications for Tanzania’s health security, ensuring that counterfeit, substandard, or unsafe medical products are effectively kept off the market. It also strengthens the country’s resilience in responding to health emergencies, pandemics, and medical supply challenges.
“Public health protection is at the heart of what we do,” he said
“By maintaining this WHO-recognized standard, TMDA guarantees that every Tanzanian, from the city to the most remote village can access medical products that meet the highest safety and quality standards.”
According to Dr Fimbo, the success is the result of dedicated teamwork, strong governance, and continuous collaboration with key national and international stakeholders.
He said the authority expressed gratitude to the government, development partners, the pharmaceutical industry, healthcare professionals, and the public for their continued support and trust.
“This achievement reflects collective effort,” said Dr Fimbo, adding that, “We extend our sincere appreciation to all partners who have walked with us on this journey to strengthen the health system and protect the wellbeing of our people.”
Dr Fimbo said retaining the WHO ML3 status also aligns with Tanzania’s broader development agenda, which emphasizes quality healthcare, good governance, and institutional accountability as key pillars of sustainable development.
Looking ahead, TMDA reaffirmed its commitment to continuous improvement and innovation, with an ambitious goal of attaining WHO Maturity Level 4 (ML4) — the highest international standard that recognizes fully mature and globally integrated regulatory systems.
“We are proud of what we’ve accomplished, but we know this is not the end,” DG Fimbo noted.
“Our focus now is to move forward to adopt new technologies, strengthen systems, and reach WHO Maturity Level 4, so that Tanzania continues to set the pace for regulatory excellence in Africa.”
