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National Institute for Medical Research (NIMR)

Advancing Health Research, Enhancing Life

NIMR

The National Institute for Medical Research (NIMR) in collaboration with the Tanzania Medicines and Medical Devices Authority (TMDA), other local and international partners, on 28th July, 2026 convened a stakeholders’ consultative meeting in Dar es Salaam to discuss strategies for strengthening Tanzania’s clinical trial oversight policy and legal framework.
The meeting, held at the CEEMI Hall, NIMR Headquarters sub-Office, brought together representatives from regulatory authorities, government institutions, research institutions, universities, ethics committees, clinical trial investigators, patient associations, and development partners to discuss findings from the assessment of Tanzania’s clinical trial oversight framework conducted using the World Health Organization (WHO) Global Benchmarking Tool (GBT).
The consultative meeting was organized under the Reinforce the Ethical and Regulatory Ecosystem for the Transformation of Clinical Trials Oversight in Ethiopia, Tanzania, and Beyond (RER-CTO) Project, which is being implemented by NIMR in collaboration with TMDA, the Armauer Hansen Research Institute (AHRI), the Ministry of Education of Ethiopia, the Ethiopian Food and Drug Authority (EFDA), the University of Oslo (UiO), and Karolinska Institutet (KI).
Speaking during the opening of the meeting, the NIMR Director General emphasized the importance of a strong ethical and regulatory oversight framework in ensuring that clinical research conducted in Tanzania protects the rights, safety, dignity, and well-being of research participants while maintaining the credibility and integrity of research outcomes.
The Director General noted that the evolving clinical research landscape, driven by advances in biotechnology, genomics, digital health, artificial intelligence, and innovative clinical trial designs, presents both opportunities and regulatory challenges. He emphasized the need for Tanzania’s clinical trial oversight framework to remain responsive and aligned with international best practices.
“This consultative meeting provides an important opportunity to discuss the findings of the assessment, identify strengths and gaps within the current framework, and agree on actions that will strengthen ethical and regulatory oversight, enhance coordination among institutions, and improve protection of research participants,” he said.
Dr. Mary Mayige, Principal Research Officer and Project Principal Investigator at NIMR Headquarters, said the meeting provided a platform for stakeholders to review findings from the RER-CTO assessment and identify priority actions for strengthening clinical trial oversight in Tanzania.
The assessment conducted through the RER-CTO Project identified key strengths and gaps within Tanzania’s existing clinical trial oversight policy and legal framework. Stakeholders discussed practical strategies and recommendations aimed at addressing the identified gaps and improving coordination among institutions involved in clinical research oversight.
Supported by the European Union through the Global Health EDCTP3 programme, the RER-CTO Project aims to strengthen ethical and regulatory systems for clinical trials in Tanzania, Ethiopia, and beyond. Through this initiative, NIMR and its partners are working to enhance research governance and support the conduct of safe, ethical, and high-quality clinical research.

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