realLaw AI Digest: July 27 – 31, 2026

The EDE has introduced mandatory pharmacovigilance standards for marketing authorisation holders

The FTA has clarified the tax accounting procedures for payments to holders of AT1 Instruments, whilst Dubai has published a new Official Gazette containing decisions relating to the Dubai Humanitarian Authority. The realLaw AI database has been updated with the latest legal reviews across ten key sectors.

Federal Level — Pharmaceuticals

01 — Mandatory pharmacovigilance standards for marketing authorisation holders

Guide on Controls and Requirements for Good Pharmacovigilance Practice for Medicinal Products, Emirates Drug Establishment (EDE)

Sets out the requirements for the marketing authorisation holder's (MAH) pharmacovigilance system, including the mandatory appointment of a Qualified Person for Pharmacovigilance (QPPV) and their deputy — both of whom must be UAE residents with relevant qualifications.

• Serious adverse reactions must be reported within 5 days

• Final reports on serious cases — within 15 days; on non-serious cases — within 90 days

• Periodic Safety Update Reports (PSURs) — 70 days after data closure (for periods of up to 12 ...