Guidelines for the conduct of good clinical practice inspections in Kenya
- Version
- Download 34
- File Size 757.95 KB
- File Count 1
- Create Date September 2, 2026
- Last Updated September 2, 2026
Guidelines for the conduct of good clinical practice inspections in Kenya
Pharmacy and Poisons Board (PPB) is the authority mandated by Cap 244 Laws of Kenya, to regulate clinical trials.
The Pharmacy and Poisons Board recognizes the importance of Research and Development of new medicines, medical devices, or procedures in the attainment of national health, social and economic goals. Clinical research must nonetheless be conducted under conditions that satisfy ethical and scientific quality standards.
PPB shall endeavor to provide a regulatory environment that avoids unnecessary delays in the clinical trial authorization process while providing safeguards for quality, efficacy, and public health. Consequently, the Expert Committee on Clinical Trials (ECCT) of the PPB has developed these guidelines to assist clinicians, researchers, pharmaceutical industry, sponsors, and investigators to easily navigate the Kenyan clinical trial authorization process.
Attached Files
