Iran

Pharmacovigilance in Iran is overseen by the Iran Food and Drug Administration (IFDA), with suspected ADR reporting through the national ADR/TTAC system. MAHs must maintain appropriate safety-reporting arrangements and comply with product-specific post-authorisation requirements. Current publicly accessible IFDA material does not establish a universal EU-style QPPV title or residency rule, an EU-style PSMF obligation for all MAHs, or a single universal PSUR/PBRER schedule. Product-specific periodic-safety and risk-management obligations therefore follow the applicable IFDA approval and post-approval requirements. Where the cited public sources do not expressly define ICSR reporting route and timelines, risk-management plan, 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.