Egypt

Pharmacovigilance activities in Egypt are regulated by the Egyptian Drug Authority (EDA) under the Guideline on Good Pharmacovigilance Practice (GVP) in Egypt, Version 3 (2026). Each local MAH must have an appropriately qualified QPPV, while a multinational MAH must nominate a Local Safety Responsible (LSR) located in Egypt. The MAH must maintain an up-to-date PSMF and, for a multinational system, a national Pharmacovigilance Sub-System File (PSSF). Valid serious ICSRs are reported within 15 calendar days and valid non-serious ICSRs within 90 days. PBRERs are submitted within 70 days for intervals up to 12 months and 90 days for intervals over 12 months; ad hoc reports follow the EDA requirement. RMP, signal-management, audit and inspection obligations also apply. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): PSMF Maintenance: Concept and Importance in Pharmacovigilance.