publicEuropean Medicines Agency · European Union · Updated Jun 12, 2026
Introduction of Mandatory Annual Safety Report (ASR) Module in CTIS
Clinical trial sponsors must update internal standard operating procedures (SOPs), conduct staff training on the functionality of the new ASR module, and utilize the CTIS training environment to ensure readiness for compliance with the new workflow.
ICSRCountry ComplianceRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, QPPV
verifiedRegulatory action: Notice
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