publicEuropean Medicines Agency (EMA) · EU · Updated Jul 22, 2026
Release of CTIS Training Module 18: How to create and submit an annual safety report (ASR)
Clinical trial sponsors must update their internal SOPs for safety reporting and ensure staff are trained on the new submission steps for ASRs through the CTIS platform.
ICSRCountry ComplianceRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, QPPV
verifiedRegulatory action: Process Change / Guidance
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