EU clinical-trial safety reporting uses more than one regulatory system. The appropriate destination depends on the type of safety information being reported.
Official resource
How the systems relate
Under the Clinical Trials Regulation, suspected unexpected serious adverse reactions (SUSARs) are reported to EudraVigilance. Other important trial-safety information, including specified unexpected events and urgent safety measures, is handled through CTIS according to the applicable process. The EMA page maps the principal report types to the relevant system and associated requirements.
Practical use
Use this resource when designing sponsor safety-reporting procedures, determining whether an event belongs in EudraVigilance or CTIS, reconciling clinical-trial safety responsibilities between safety and regulatory teams, or reviewing inspection readiness around SUSAR and urgent-safety-measure workflows.
The page is an operational entry point and should be read together with the Clinical Trials Regulation, its implementing guidance and current CTIS/EudraVigilance technical instructions where the exact legal or technical requirement is needed.