Kenya has officially joined the TRACE Project, a major African initiative working to improve the speed, transparency and efficiency of clinical trial approvals without compromising patient safety.
The move places Kenya alongside Rwanda, Nigeria, Tanzania and Zimbabwe in a growing regional effort focused on modernizing research ethics and regulatory systems.
The initiative brings together key Kenyan institutions including the National Commission for Science, Technology and Innovation (NACOSTI), the Pharmacy and Poisons Board (PPB), the Kenya Medical Research Institute (KEMRI), and Moi Teaching and Referral Hospital/Moi University College of Health Sciences.
Under the new framework, Kenya will introduce parallel review systems between ethics committees and regulators, helping reduce delays in approving clinical trials. The reforms also include digital integration of review systems, reviewer training, and stronger oversight mechanisms aimed at cutting protocol review timelines to less than 60 days.
The TRACE Project says the broader goal is to strengthen Africa’s ability to respond quickly to public health emergencies and accelerate access to life-saving medical innovations through more efficient regulatory systems.
Across the continent, TRACE has already recorded progress in several countries. Zimbabwe is developing a fully integrated digital platform for clinical trial submissions and reviews, while Rwanda has finalized technical specifications for a National Digital Ethics Review System.
Nigeria is also reviewing its national health research ethics code, while Tanzania continues strengthening clinical trial oversight through training and the development of traditional medicine research guidelines.
The TRACE consortium is expected to meet in Harare in June to assess progress and coordinate the next phase of implementation across participating countries.
