Kenya

Pharmacovigilance in Kenya is overseen by the Pharmacy and Poisons Board (PPB), National Pharmacovigilance Centre, under the Pharmacy and Poisons (Pharmacovigilance and Post-Marketing Surveillance) Rules, 2022 and PPB guidance. The MAH must appoint a QPPV and maintain a PSMF in accordance with the PPB guideline for establishment of QPPVs, with the system available for PPB review and inspection. Under the cited PPB safety and vigilance guidance, fatal local cases are reported within 7 calendar days, serious non-fatal local cases within 15 days, and non-serious local cases within 30 days; foreign cases are handled through the applicable periodic safety-reporting route. PSUR/PBRER, signal, risk-minimisation and inspection obligations apply under PPB requirements and product status. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): How to Prepare and Comply with a Pharmacovigilance Inspection.