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By Chinenye Anuforo
Kenya has joined a major African initiative seeking to modernise and accelerate clinical trial approval processes through digital innovation, parallel review systems and stronger regulatory collaboration.
The country’s entry into the TRACE Project (Trial Regulation and Clinical Ethics Optimization) expands the regional programme already operating in Nigeria, Rwanda, Tanzania and Zimbabwe.
The initiative is designed to improve the transparency, predictability and efficiency of ethics and regulatory reviews for clinical trials across Africa, while ensuring participant safety and compliance with global standards.
Under the Kenyan rollout, key institutions including the National Commission for Science, Technology and Innovation (NACOSTI), the Pharmacy and Poisons Board (PPB), the Kenya Medical Research Institute (KEMRI), and the Moi Teaching and Referral Hospital/Moi University College of Health Sciences Institutional Scientific and Ethical Review Committee will collaborate to streamline approval processes for medical research.
A major feature of the reform is the introduction of parallel review mechanisms between ethics committees and regulators, replacing slower sequential processes that often delay approvals.
The programme will also deploy enhanced digital platforms to support electronic submission, review and tracking of clinical trial applications, alongside improved data management and interoperability among regulatory institutions.
According to TRACE Project officials, the reforms are expected to significantly reduce review timelines, with a target of completing protocol assessments within 60 days.
The project further includes capacity-building initiatives for ethics and regulatory reviewers, development of standardised review tools, and strengthening of institutional oversight frameworks to improve accountability and consistency in decision-making.
The TRACE consortium said the move reflects a growing continental push to strengthen Africa’s clinical research ecosystem and position the region for faster response to emerging public health challenges.
Recent developments under the initiative include Zimbabwe’s progress on a fully integrated Clinical Trials and Protocol Processing System, Rwanda’s work on a National Digital Ethics Review System, and Nigeria’s ongoing review of its National Code of Health Research Ethics.
In Tanzania, regulators are also developing national guidelines for traditional medicine research as part of efforts to align local scientific practices with international ethical standards.
The consortium is expected to hold its second face-to-face regional meeting in Harare next month to assess progress and coordinate the next implementation phase across participating countries.
