Primary source: EMA - What's new RSS
Guidance issued for mandatory use of the New Safety Module for ASR submission starting from 28 September 2026, affecting how clinical trial sponsors report safety information.
The shift to the New Safety Module standardizes the reporting process for clinical trials in the EU and ensures compliance with updated regulatory requirements, impacting how sponsors manage safety data.
Sponsors must prepare for training on the new module and transition to its use for ASR submissions while ensuring all trial authorizations align with the timeline.
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Sponsors must prepare for training on the new module and transition to its use for ASR submissions while ensuring all trial authorizations align with the timeline.
The EMA has introduced a new safety module for the Annual Safety Report (ASR) as part of the Clinical Trial Information System (CTIS). The new module will be integrated into the CTIS Sponsor Workspace on 28 September 2026, requiring all new ASRs to be submitted through this module after the go-live date. A two-month transition period will allow both the old and new functionalities to be used in parallel.
What changed: Guidance issued for mandatory use of the New Safety Module for ASR submission starting from 28 September 2026, affecting how clinical trial sponsors report safety information.
Why it matters: The shift to the New Safety Module standardizes the reporting process for clinical trials in the EU and ensures compliance with updated regulatory requirements, impacting how sponsors manage safety data.
Practical implication: Sponsors must prepare for training on the new module and transition to its use for ASR submissions while ensuring all trial authorizations align with the timeline.
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