Kenya joins African push for faster clinical trial approvals

Kenya has joined a major African initiative aimed at reducing delays in clinical trial approvals, in a move expected to strengthen the continent’s capacity to attract medical research investments and speed up access to life-saving treatments.

The country formally joined the Trial Regulation and Clinical Ethics Optimization (TRACE) Project, a regional programme designed to improve the speed, transparency and efficiency of clinical trial reviews across Africa.

With Kenya’s entry, the initiative now includes Nigeria, Tanzania, Rwanda and Zimbabwe, creating a growing continental alliance focused on modernising Africa’s clinical research systems and aligning them with global standards.

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The programme is being implemented through collaboration among key Kenyan institutions, including the National Commission for Science, Technology and Innovation, the Pharmacy and Poisons Board, the Kenya Medical Research Institute, and the Moi Teaching and Referral Hospital/Moi University College of Health Sciences Institutional Scientific and Ethical Review Committee.

Under the initiative, Kenya will adopt a parallel review system that allows ethics committees and drug regulators to assess clinical trial applications at the same time instead of separately. Experts say the reform could significantly reduce approval delays that have often slowed medical research across many African countries.

The TRACE consortium said the reforms are expected to reduce protocol review timelines to less than 60 days while still maintaining strict patient safety and ethical standards.

The initiative also seeks to improve digital systems used for clinical trial applications and approvals. Kenya plans to strengthen workflow management, improve interoperability among institutions involved in research oversight and introduce more efficient electronic review systems.

Africa has long struggled with fragmented and slow regulatory systems that discourage pharmaceutical companies and global research organisations from conducting trials on the continent. Delayed approvals often mean African patients get late access to new vaccines, medicines and therapies.

By harmonising review processes and improving coordination among regulators and ethics bodies, TRACE aims to position African countries as more competitive destinations for global clinical research.

The project will also support reviewer training, standardisation of review tools, continuous professional development for ethics and regulatory officials, and stronger accreditation systems for Institutional Review Boards.

Across participating countries, the project has already recorded progress in strengthening clinical research governance.

In Zimbabwe, work is ongoing on an integrated Clinical Trials and Protocol Processing System that will support electronic submission and review of research protocols.

Rwanda has completed technical specifications for a national digital ethics review platform that will allow parallel submissions alongside the Rwanda Food and Drugs Authority.

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The project has also contributed to the review of Rwanda’s Standard Operating Procedures for ethics oversight and supported the ongoing revision of Nigeria’s National Code of Health Research Ethics to strengthen clinical trial review systems and reliance frameworks.

In Tanzania, the National Institute for Medical Research has expanded mentorship and training programmes for regulators, ethics committee members and researchers. The country is also developing national traditional medicine research guidelines to align local research practices with international ethical standards.

Health sector stakeholders believe the initiative could help Africa reduce dependence on foreign regulatory systems while building stronger local capacity for medical innovation and public health research.

The TRACE consortium is expected to meet in Harare next month to assess progress across participating countries and coordinate the next phase of implementation activities aimed at transforming clinical trial governance on the continent.