Israel

Pharmacovigilance activities in Israel are regulated by the Ministry of Health's Risk Management and Drug Information Department. The current framework includes Procedure No. 6 on reporting adverse events and new safety information (updated 1 April 2026) and product-specific risk-management requirements. The MAH must establish pharmacovigilance arrangements, appoint a locally approved QPPV with an appropriate back-up, collect and report adverse events and new safety information, and submit periodic safety information when required. An Israel-adapted RMP is required when instructed by the Ministry; the official procedures do not impose an EU-style PSMF as the standard named document. Where the cited public sources do not expressly define signal management and audit and inspection arrangements, the MAH should confirm the current product-specific requirements with the competent authority and against the marketing-authorisation conditions. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.