DME List — Designated Medical Events

EMA list of inherently serious, often medicine-related events used to support safety-signal review.

Resource family Signals & Safety Communications
Resource type Medical Event Reference List
Maintained by European Medicines Agency
Jurisdiction European Union
Status Regulatory reference resource
Access Public
Official link verified 2026-10-17
Official source Visit official resource ↗

The Designated Medical Events (DME) list identifies medical conditions that are inherently serious and often medicine-related. It supports signal review; inclusion does not establish causality in an individual case.

Use the Designated medical events section of the official EMA signal-management page for the list. EMA notes that it does not address product-specific issues or conditions with high prevalence in the general population.

Read the QPPV guide to designated medical events.

QPPV.com