Research into tuberculosis, HIV and malaria accounts for 50 percent of all active clinical trials in Kenya, making it the largest research area in the country. According to the Pharmacy and Poisons Board (PPB), 67 of the 134 active trials fall under this category. This emphasizes the country's ongoing involvement in research targeting infectious and tropical diseases.
The PPB's chief executive, Ahmed Mohamed, stated that the main areas of research include tropical and infectious diseases, particularly tuberculosis, HIV and malaria, with 67 applications. Other areas of research include vaccines, chronic diseases, and medical technologies and devices. Overall, 398 trials have been completed, while 134 are still active. A further 16 applications have been withdrawn, 11 suspended and four rejected.
Chronic diseases, including cancer and hypertension, are the second largest area of research, with 47 trials. Medical devices account for 12 trials, while vaccines account for eight. Dr. Mohamed noted that two trials for malaria vaccines have resulted in these vaccines being registered locally. These vaccines have demonstrated a reduction in deaths among vulnerable populations, including children and women.
Once the research has ended, a post-trial access programme is incorporated into Kenyan regulations to ensure the continued availability of beneficial medicines until treatments are publicly available. This research activity comes as Kenya seeks to strengthen its clinical trial regulatory system and attract more research investment.
In June, the PPB issued the sixth revision of its clinical trial guidelines, aligning the framework with the International Council for Harmonisation's Good Clinical Practice standards, known as ICH E6(R3). The revised guidelines strengthen several areas, including trial monitoring, safety reporting, protocol amendments, progress reporting, and access to source data and documents.
The updated framework also allows for the continued monitoring of approved trials and requires researchers to report protocol deviations and violations, challenges encountered during the study, and the trial's current status. Despite being a site for infectious disease research, supported by research institutions, hospitals and international sponsors, the number of new applications has declined in recent years.
The country's clinical research environment is supported by improvements in review processes, research infrastructure, and regulatory systems. However, new applications have fallen from 76 in 2023 to 73 in 2024 and then to 59 in 2025. In the first eight months of this year, the Board received 40 applications.
Key points
- Research into tuberculosis, HIV and malaria accounts for 50 percent of all active clinical trials in Kenya.
- The country has long been a site for infectious disease research, supported by research institutions, hospitals and international sponsors.
- The number of new applications has declined in recent years, falling from 76 in 2023 to 59 in 2025.
