Current status of the new Safety Module
Pre-go-live status: the module is available in the CTIS training environment. EMA foresees production go-live on 28 September 2026. From that date, the guidance says all newly created ASRs should use the new module and creation of new ASRs in the old functionality should be disabled.
EMA foresees a two-month transition for ASRs already under assessment in the old functionality. The current guidance places the end of that transition on 28 November 2026.
Because those dates are described by EMA as foreseen, sponsors should confirm the current EMA status if using this guide after 28 September 2026.
What the ASR covers
Article 43 of the Clinical Trials Regulation requires sponsors to submit an annual report on the safety of each investigational medicinal product other than placebo. The ASR supports ongoing evaluation of the safety profile of the IMP and the mitigation of potential risks.
The current Sponsor Handbook states that the obligation starts with the first authorisation of a trial involving the concerned IMP and ends with the end of the last trial conducted by the sponsor with that IMP.
ASR documents, ASR RFIs and their structured data are not published in CTIS.
Responsibility and workflow map
Sponsor Admin or Sponsor Safety Admin manages the relevant safety access. The operational role for preparing and submitting the ASR is ASR Submitter.
Create either a Clinical Trial-centric ASR for one trial or a Substance Group-centric ASR covering the applicable trials linked to a substance group.
Confirm the trial or substance-group scope, sponsor information, reporting-period information and supporting documents.
Use CTIS validation before submission and resolve missing or inconsistent mandatory information.
The assessing Member State coordinates assessment. The ASR Submitter must monitor notices and respond to any RFI by the stated deadline.
ASR roles and access
Manages sponsor-level access and can assign relevant safety roles.
Manages safety-role assignments in the Safety user-management area.
Creates and submits ASRs within the assigned scope and is the sponsor role that can view and respond to ASR RFIs.
CT Admin is not enough. EMA states that the CT Admin role does not itself provide ASR permissions. A CT Admin who needs to perform ASR activities must also receive the ASR Submitter role.
Choose the ASR approach before entering the report
One ASR covers one clinical trial. EMA states that the assessing Member State is by default the Reporting Member State of that trial.
One ASR covers the applicable trials associated with a CTIS Substance Group. The safety assessing Member State appointed for that group leads the coordinated assessment.
Only trials within the ASR Submitter's assigned scope can be selected. EMA also states that ASR access is controlled independently from access to the trial record elsewhere in CTIS.
Complete the four ASR sections
- Substance Group or Clinical Trial details: select the correct reporting scope and confirm the trial or trials covered.
- Sponsor information: review the sponsor and applicant information and confirm the contact information used for the submission.
- ASR reporting-period details: enter the reporting period and the safety information requested by the module, including the applicable reference safety information fields.
- Supporting documents: upload the ASR and the supporting documents required for the case, with complete document metadata.
Before creating the ASR, EMA advises the ASR Submitter to check that there is no ongoing change-of-sponsor assessment for the relevant trial or trials.
Pre-submission quality check
- Confirm that the correct Clinical Trial or Substance Group approach was selected.
- Check that every included trial falls within the ASR Submitter's assigned scope.
- Verify sponsor, applicant and contact details before submission.
- Check the reporting period and safety fields for internal consistency.
- Confirm that the ASR and supporting documents are uploaded in the intended locations with complete metadata.
- Use the CTIS document naming convention for clear, consistent document titles.
Assessment and RFI handling
Under Commission Implementing Regulation (EU) 2022/20, Member States should conclude the coordinated ASR assessment within 42 days, or within a maximum of 84 days when an RFI is raised.
The ASR Submitter receives the RFI through the Safety workflow and should actively monitor CTIS notices after submission.
The Sponsor Handbook states that CTIS sets the sponsor response deadline to 14 days by default. The assessing Member State can shorten that deadline before sending the RFI.
When assessment is finalised, the sponsor can see the Summary & Conclusions. Draft and Final Assessment Reports remain authority documents and are not visible to the sponsor.
Transition from the old ASR functionality
EMA foresees the old and new workflows operating in parallel only for ASRs that were already under assessment when the new module goes live. The guidance says new ASRs should be created in the new module from the foreseen go-live date.
For old-workflow ASRs that remain open during the transition, EMA advises sponsors to retain the relevant submission, RFI and response records before the old functionality is removed.
Check the current known-issues list before submission
The September 2026 sponsor guidance contains an annex of known issues and workarounds for the new Safety Module. Because those issues can change as the module is deployed, use the current EMA guidance rather than relying on a static list copied into an SOP or checklist.
If a correction requires a change to the trial dossier itself, classify that change separately. The substantial vs non-substantial modification guide explains the CTIS routing logic.
Official sources and resources
- EMA Sponsor Guidance: New Safety Module on the Annual Safety Report, EMA/178285/2026, first published 31 July 2026 and updated 3 September 2026.
- EMA CTIS training and support, including the current Sponsor Handbook.
- Commission Implementing Regulation (EU) 2022/20 on coordinated safety assessment.
- European Commission EudraLex Volume 10.
Last reviewed: 19 September 2026