Rwanda has reduced clinical trial approval timelines by more than 70 per cent through reforms and improved processes, according to Food and Drugs Authority (FDA).

The Trial Regulation and Clinical Ethics Optimization (TRACE) project, funded by the Gates Foundation, building on earlier national reforms, has contributed significantly to this achievement, a development stakeholders expect will make the country more attractive to international research sponsors, pharmaceutical companies and clinical trials investigators.

TRACE Rwanda was implemented by CIIC-HIN (www.ciichin.org) in collaboration with Rwanda National Ethics Committee (RNEC) and Rwanda FDA since 2024 to 2026 under the coordination of Garnet Partners.

The progress was highlighted during a two-day TRACE project closeout workshop held in Kigali on October 29-30, which brought together regulators, members of the Rwanda National Ethics Committee (RNEC), and institutional review boards (IRBs) , researchers, academic institutions and development partners to assess achievements and discuss how to sustain the reforms.

Launched in April 2025, with funding from the Gates Foundation, TRACE is being implemented in five African countries: Rwanda, Nigeria, Tanzania, Zimbabwe and Kenya, which joined in May 2026. Rwanda was the first participating country to complete implementation within the planned timeframe.

Dr. Nathalie Umutoni, TRACE Rwanda project lead and Managing Director of PACT Solutions, a Rwanda-based contract research organisation (CRO), that include the role of PACT in trace project and add working with other partners in the project, said the project sought to address few timeline challenges and unpredictable approval processes that researchers faced when seeking authorisation for clinical studies.

The contribution of TRACE project in the clinical trial ecosystem was voiced by IRBs members, researchers in academic institutions during the closeout meeting.

"The three objectives of the project were to achieve transparency, predictability and efficiency of processes,” she said.

Previously, researchers often had to complete separate approval processes involving the Rwanda National Research Ethics Committee (RNEC) and Rwanda Food and Drugs Authority (Rwanda FDA), sometimes waiting for one institution&039;s decision before approaching the other.

Through TRACE, RNEC completed the mapping of its review processes, developed and finalised its standard operating procedures (SOPs), and launched a website with an embedded workflow and calendar showing researchers when to submit applications and when to expect feedback. A one-application portal and review process is also expected soon. It will allow RNEC and the Rwanda FDA to assess applications simultaneously, without returning the package separately to researchers.

"This really changed the whole story. There is no wasting of time,” she said.

Digital systems, risk-based fees aim to streamline research approvals

The project supported improvements to RNEC's website, which now provides 38 searchable and downloadable documents including SOPs, application forms and templates. For more information visit RNEC.

A digital research ethics review platform is developed to manage applications throughout the review process, from registration and payment to screening, committee decisions, certificate issuance and post-approval oversight.

This platform offers an unified application portal from Rwanda FDA and RNEC to improve on the application and review timelines while aligning comments from both institutions. This will reduce the time to get feedback to the researcher. The oversight post approval is also embedded within the system.

The proposed six-stage system is designed to allow applicants to track submissions and provide a record of decisions. It is also expected to integrate with Rwanda FDA's digital system and the Irembo government service portal to facilitate coordinated submissions and electronic payments.

The platform is expected to include a locally hosted artificial intelligence model that can flag application content requiring attention, check it against relevant procedural requirements and cite applicable provisions. Its findings will be advisory, with human reviewers retaining responsibility for decisions.

Dr. Marie-Françoise Mukanyangezi, a senior lecturer at the University of Rwanda and Secretary of RNEC, expects the system to reduce administrative workloads, improve the quality of feedback to researchers and shorten the time between application submission and final approval, after testing.

TRACE also supported changes to ethics review fees, with charges categorised according to research risk and the level of review required.

Faster approvals and regulatory oversight

At Rwanda FDA, the project supported improvements to digital systems, regulatory procedures and collaboration with RNEC.

Dr Alphonse Ndayambaje, Team Lead Clinical Trial Analyst and Lead Good Clinical Practice (GCP) Inspector at Rwanda FDA, said the authority reviewed its guidelines and procedures to strengthen coordination and harmonise oversight.

He cited Rwanda's response to the 2024 Marburg outbreak as an example of the importance of efficient regulatory processes, saying the country approved a clinical trial in record time to support the public health response.

"From the baseline, more than 70 per cent reduction in timelines has been achieved,” he said.

He attributed the improvement to parallel reviews, digitalisation and reduced duplication of processes.

However, speakers at the workshop noted that faster approvals must go hand in hand with the continuous demonstrated safeguarding processes to protect the rights, safety and well-being of research participants.

Sustaining the reforms

The closeout discussions highlighted the need for institutions to take responsibility for maintaining the digital systems, updating procedures, training staff and financing the improvements.

TRACE has contributed to the clinical trial ecosystem in Rwanda and the stakeholders involved in TRACE are committed to sustain the gains. Findings from Trace Project are expected to increase the benefit of the entire population through access to new interventions and opportunities to participate in clinical trials.