Pharmacovigilance Summary Report: April 1st to June 30th 2023 (Q4)

The Pharmacy and Poisons Board is the Drug Regulatory Authority established under the Pharmacy and Poisons Act, Chapter 244 of the Laws of Kenya. The Board regulates the Practice of Pharmacy and the manufacture and trade of drugs and poisons. PPB has 4 directorates of which the Directorate of Product Safety (PDS) is responsible for Pharmacovigilance, Post-Market Surveillance, Clinical Trials & Medicines Information activities. PDS shares quarterly pharmacovigilance reports with stakeholders to serve as a feedback mechanism and also encourage all stakeholders to report. Since the introduction of PV in Kenya, a total of 16,693 individual case safety reports has been submitted to the global data reports 36,188,840 (0.05%).