Pharmacovigilance Summary Report: Quarter 4 (April 1st to June 30th 2024) 2023/2024

The Pharmacy and Poisons Board is the National 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.

The PPB has 4 directorates of which the Department of Product Safety (PDS) under the Health Product and Technologies Directorate is responsible for Pharmacovigilance, Post- Marketing 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 adverse events.

Since the introduction of PV in Kenya, a total of 19,754 individual case safety reports (ICSRs) have been submitted to the global database representing 2.7% of the total ICSRs submitted by African countries.