ADVOKS GLOBAL · KENYA
Pharmacy and Poisons Act
25A. Clinical trials
Edition: 2023-12-11 · In force
25A. Clinical trials
(1)A pharmaceutical product shall not be used for clinical trial unless an approval is granted by the Board with the approval of the relevant ethics body.(2)Any person who intends to commence a clinical trial on a pharmaceutical product shall make an application to the Board in the prescribed form and the application shall be accompanied by the study protocol in the prescribed format and the prescribed fee.(3)The study protocol submitted under subsection (2) shall include a post- trial access program to ensure access of investigational medicinal substances by participants in a trial before grant of marketing authorization by the Board.(4)The Board shall prescribe guidelines for evaluation of applications made under subsection (2) to be implemented for accelerated evaluations during emergency situations, epidemics and outbreaks.(5)A person granted an approval under section 25A(1) shall put up a robust quality assurance system to ensure that the clinical trial is carried out so as to ensure the integrity of data generated, the safety and well-being of study participants.(6)The Board shall carry out inspections of the clinical trials so as to ensure compliance of the clinical trials with the prescribed requirements.