Dodoma — THE Tanzania Medicines and Medical Devices Authority (TMDA) has successfully retained the World Health Organisation (WHO) Maturity Level 3 (ML3) status for its Medicines and Vaccines Regulatory System, following a comprehensive reassessment conducted by the Global Health body in 2023.
In a statement issued over the weekend in Dodoma, TMDA Director General Dr Adam Fimbo announced the achievement, describing it as a reflection of the Authority's commitment to regulatory excellence, transparency, professionalism and adherence to internationally recognised standards that ensure the quality, safety and efficacy of health products.
Tanzania made history in 2018 when TMDA became the first regulatory authority in Africa to attain WHO ML3 status.
"Maintaining this position following the 2023 verification audit demonstrates the sustainability of Tanzania's regulatory systems and highlights TMDA's leadership and significant contribution to public health protection," said Dr Fimbo.
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He noted that this milestone is a crucial boost to the country's healthcare system, as it assures the public of the quality, safety and effectiveness of medicines and vaccines.
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It also plays a key role in preventing the circulation of substandard or counterfeit products and enhances the country's ability to respond effectively to health emergencies, including disease outbreaks.
Dr Fimbo further stated that retaining the WHO ML3 status affirms TMDA's ongoing efforts to strengthen its regulatory frameworks, positioning Tanzania as a regional and global leader in health regulation.
The achievement enables the country to participate more actively in joint regulatory programmes, expand access to international markets and attract investment in the pharmaceutical and medical devices sectors.
He invited Tanzanians to take pride in this national accomplishment and extended appreciation to development partners, stakeholders, health professionals and the general public for their continued support in safeguarding public health.
According to WHO, Maturity Level 3 signifies a stable, well-functioning and integrated regulatory system, a benchmark for international best practices.
TMDA is an executive agency under the Ministry of Health, mandated to regulate the quality, safety and effectiveness of medicines, medical devices, diagnostics, biocidal products and tobacco-related products in Tanzania.
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