Research into tuberculosis (TB), HIV and malaria accounts for 50 percent of all active clinical trials in Kenya across four main categories listed by the Pharmacy and Poisons Board (PPB), making it the largest research area in the country.
Clinical trials are a type of research that studies new tests and treatments and evaluates their effects on human health outcomes.
Ahmed Mohamed, the PPB’s chief executive, told the Business Daily that 67 of the 134 active trials fall under this category, emphasising the country’s ongoing involvement in research targeting infectious and tropical diseases.
This is followed by 47 trials involving chronic diseases, including cancer and hypertension. Medical devices account for 12 trials, while vaccines account for eight.
“The main areas of research include tropical and infectious diseases, particularly tuberculosis, HIV and malaria, with 67 applications, vaccines, chronic diseases, and medical technologies and devices,” said Dr Mohamed.
Overall, 398 trials have been completed, while 134 are still active. A further 16 applications have been withdrawn, 11 suspended and four rejected.
“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,” said Dr Mohamed.
“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.
There are no changes or additional requirements for the industry. These were already implemented informally; the guideline provided clarity on the requirements,” said Dr Mohamed.
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.
Kenya has long been a site for infectious disease research, supported by research institutions, hospitals and international sponsors.
“The country’s clinical research environment is supported by improvements in review processes, research infrastructure, and regulatory systems,” said Dr Mohamed.
However, the number of new applications has declined in recent years, falling 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.
