UAE Drug Regulator Says Safety Reports Led to 78 Regulatory Actions Since 2025

The figures, released for this week's national drug safety campaign, are among the most detailed the federal regulator has published on its pharmacovigilance work. For drug makers and distributors, they show how often reports of side effects lead to action against a product on the UAE market.

The regulator said it received 5,840 reports of suspected adverse drug reactions in 2025 and 5,122 between January 1 and September 30, 2026, a total of 10,962. The nine-month figure for this year is already close to 2025's full-year total. The regulator cautioned that a report does not prove the drug caused the reported symptoms. It said each case is weighed with other safety data, including periodic reports, risk management plans and post-approval studies, and that it prioritises cases that may threaten life, need hospital admission or cause serious harm.

The outcome of a review can range from updating the safety information in a product leaflet to adding warnings or restricting use in certain groups of patients. Where the evidence warrants it, the product can be suspended or recalled.

The regulator has also tightened its rules. Decision No. 27 of 2026 adopted a guide to good pharmacovigilance practice that sets out each party's responsibilities and how safety signals are handled, from detection through to a recommended action. Under the guide, serious adverse reactions must be reported initially as soon as possible and within five days at most of becoming aware of them. Final reports are due within 15 days for serious cases and 90 days for non-serious ones.

The awareness campaign runs from November 2 to 8, alongside the global medication safety week. It includes sessions run by the Emirates Health Services, the Dubai Health Authority and the Sharjah Health Authority for pharmacists, healthcare facilities and practitioners. There are also meetings with the public and the pharmaceutical industry. Patients can report suspected side effects by email to [email protected], and healthcare facilities and practitioners can use an electronic service on the regulator's website.