Jordan

Pharmacovigilance activities in Jordan are regulated by the Jordan Food and Drug Administration (JFDA) under its national pharmacovigilance guidance, including the updated guidance package launched in July 2026. The MAH must establish a pharmacovigilance system and designate a qualified pharmacovigilance person or Local Safety Responsible, with a registered back-up, maintain appropriate PSMF documentation, report adverse events and comply with applicable PSUR/PBRER and RMP requirements. 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): PSMF Maintenance: Concept and Importance in Pharmacovigilance.