Reinforce the Ethical and Regulatory Ecosystem for the Transformation of Clinical Trials Oversight in Ethiopia, Tanzania and beyond

Project Information

RER-CTO

Grant agreement ID: 101145815

DOI

10.3030/101145815

EC signature date 11 June 2024

Start date 1 July 2024

End date 30 June 2027

Funded under

• Health

Total cost

€ 926 152,50

EU contribution

€ 926 152,50

Coordinated by

UNIVERSITETET I OSLO
Norway

Periodic Reporting for period 1 - RER-CTO (Reinforce the Ethical and Regulatory Ecosystem for the Transformation of Clinical Trials Oversight in Ethiopia, Tanzania and beyond)

Reporting period: 2024-07-01 to 2025-12-31

Summary of the context and overall objectives of the project

The RER-CTO project's overarching goal is to strengthen and harmonise clinical trial oversight, legal and policy frameworks in Ethiopia and Tanzania by aligning national regulatory instruments with evidence-based international best practices and the WHO Global Benchmarking Tools (GBT). Ethiopia and Tanzania face several practical and structural challenges stemming from fragmented legal frameworks, limited harmonization, slow, paper-based review processes, and gaps in regulatory and ethical capacity. At the same time, both countries are increasingly involved in multi-country clinical research and are working toward alignment with WHO Global Benchmarking Tools and regional reliance approaches. Strengthening oversight systems is therefore essential for protecting research participants, building regulatory credibility, and ensuring timely access to new and improved health technologies. Thus, RER-CTO’s objectives are:
1. Reinforcing policy and legal framework for clinical trial oversight
2. Improving Regulatory and Research ethics oversight capacity and capability
3. Strengthening local, regional, and international collaborations and coordination of NECs and NRAs for clinical trial oversight by developing joint clinical trial review guidelines.
The project is divided into seven work packages (WPs) with a single goal of harmonized, digitally enabled clinical trial oversight systems aligned with international best practices while reflecting unique national realities. The WPs pathway to impact combines governance, scientific leadership, legal and policy reform, digital systems strengthening, capacity building, and regional collaboration.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

In WP1, the Project Management Plan and Data Management Plan were developed and finalized. In WP2, baseline evidence was generated on the current regulatory and ethical oversight of clinical trials, including assessments of human resources, infrastructure, skills, and systems capacity. The findings are being utilized to inform and guide capacity-building activities. In WP3, a regulatory framework and policy study was conducted in four African countries. The findings are now available to support strategy development and harmonization efforts. In WP4, the digitalization of the protocol review process in Ethiopia at EFDA and NRERB has been completed, and system optimization activities were completed in Tanzania at TMDA and NIMRI. This was achieved through needs assessment, system specification development, and piloting of the proposed system. In WP5, a training curriculum was developed based on the identified needs assessment findings and is now ready for implementation.
In WP6, a joint review guideline was drafted to facilitate collaborative review of clinical trial applications between National Regulatory Authorities (NRAs) and National Research Ethics Committees (NECs), both within and across participating countries.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Improved policy and legal frameworks for clinical trials oversight in sub-Saharan Africa
A comprehensive desk review of existing legal and policy frameworks governing clinical trial oversight in both Ethiopia and Tanzania has been completed. This review systematically identified critical gaps, overlaps, and areas requiring revision, thereby providing a strong evidence base for the development and updating of national guidelines, policies, and legal instruments.
The development of new guidelines and the revision of missing or outdated policy and legal frameworks are expected to significantly strengthen clinical trial oversight systems. In Ethiopia, these efforts have already helped the country achieve WHO Global Benchmarking Tool (GBT) maturity level 3 by the end of 2025, demonstrating a functional and well-integrated regulatory system. These results will contribute to enhanced functionality, credibility, and performance of National Regulatory Authorities (NRAs) and National Ethics Committees (NECs) across SSA.

Improved efficiency of clinical trial oversight systems within National Regulatory Authorities and National Ethics Committees
Digitalization of protocol submission, review, and management systems has been initiated from the ground up for the Ethiopian Food and Drug Authority (EFDA) and the National Research Authority at the Ministry of Education (MoE), and these systems are now ready for implementation. In parallel, system optimization and enhancement have been implemented at the National Institute for Medical Research (NIMR) and the Tanzania Medicines and Medical Devices Authority (TMDA). These improvements enable more streamlined, transparent, and coordinated processes for clinical trial protocol authorization and oversight.

Increased capacity of National Regulatory Authorities and National Ethics Committees members for efficient clinical trial oversight
To strengthen human resource capacity, tailored training curricula have been developed based on a comprehensive needs assessment of professionals involved in clinical trial oversight. These curricula address key competency gaps and are designed to enhance technical, ethical, and regulatory skills required for high-quality oversight. The improved competencies of NRA and NEC professionals will directly contribute to higher-quality, more consistent, and more efficient review and monitoring of clinical trials. This capacity-building approach will support the development of a better-equipped, resilient health research system capable of integrating new or improved health technologies. It will also promote sustainable health research practices within NECs and NRAs across SSA.