United Arab Emirates

Pharmacovigilance in the United Arab Emirates is regulated by the Emirates Drug Establishment (EDE) under Decision No. 27 of 2026 adopting the UAE Good Pharmacovigilance Practice Guideline. The MAH must maintain a pharmacovigilance system and provide an approved qualified person and deputy who both reside in the UAE, with 24/7 contact arrangements. The PSMF must include global and local safety information and be submitted to EDE; an NPVSF is mandatory for medical products manufactured in the UAE, and the applicable file is kept at the pharmaceutical establishment where the qualified person works. Serious final reports are due within 15 days and non-serious final reports within 90 days; RMP/risk-minimisation, PSUR, signal-management, inspection and record-retention requirements also apply. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): PSMF Maintenance: Concept and Importance in Pharmacovigilance.