The Emirates Drug Establishment (EDE) is the federal authority responsible for regulating medicines and pharmacovigilance in the United Arab Emirates.
Core official resources
- EDE legislation directory — includes the 2026 resolution approving the Pharmacovigilance Practice guideline for medical products.
- Approval of the Pharmacovigilance Officer — official service and documentation requirements for the UAE pharmacovigilance officer/QPPV.
- Approval of the Pharmacovigilance Plan — company PV-plan evaluation service covering governance, QPPV responsibilities, ICSRs and PSUR/PBRER requirements.
- Reporting side effects — official EDE reporting route for adverse reactions.
Practical use
The UAE framework is now EDE-led rather than relying on older MOHAP pharmacovigilance pages. EDE explicitly requires appointment and approval of a responsible pharmacovigilance officer and provides a dedicated service for approval of the company's pharmacovigilance plan.