TRACE PROJECT SCOPING MISSION IN RWANDA

KIGALI – DECEMBER, 2024

The TRACE project scoping mission was held in Kigali on 13 December 2024 at Hôtel des Mille Collines, marking a key step toward strengthening Rwanda’s clinical trial regulatory and ethics systems. The meeting brought together representatives from The Gates Foundation, CIIC-HIN, Garnet Partners, Rwanda FDA, RNEC, Institutional Review Boards (IRBs), selected district hospitals, academic partners and stakeholders that each play a crucial role in Rwanda’s clinical trial oversight, ethical review, regulatory decision-making, and research implementation. 

The meeting participants emphasized the need for a coordinated national approach to strengthen ethics oversight through mentorship, training, and evidence-based tools. Dr. David Mukanga from the Gates Foundation outlined the objectives of the scoping mission, including the importance of improved transparency, efficiency, and predictability in ethics review through digital enhancement and national accreditation systems managed by the national ethics committees. 

RwandaFDA’s representative, Dr. Alphonse Ndayambaje presented ongoing progress toward streamlined clinical trial approvals throughthe national digital portal (IRIMS), while RNEC leadershiphighlighted Rwanda’s achievement of standardized30-day ethics review timelines and the country’s commitment to aligning with continental and international best practices. Following the mission, stakeholders endorsed the development of a national country plan, which was subsequently submitted in March 2025.