EMA’s New CTIS Safety Module for Annual Safety Reports: Sponsor and Member State Guidance
The European Medicines Agency (EMA) has published two complementary guidance documents explaining the new CTIS Safety Module for Annual Safety Reports (ASRs). Together, they describe the end-to-end process for ASR submission, assessment, safety issue management and finalisation.
The Sponsor Guidance explains how sponsors will prepare, submit and manage Annual Safety Reports through the new Safety Module.
Transition to the New Safety Module
The new Safety Module will replace the existing ASR submission functionality in CTIS. A two-month transition period is planned, during which both the existing and new functionality will be available. New ASRs submitted after the transition begins should use the new Safety Module, while ongoing ASRs in the previous system can be finalised during the transition period. Sponsors are advised to download relevant ASR submissions and RFI responses before the transition period ends.
ASR Submission
Sponsors can submit an ASR using either a Clinical Trial-centric or Substance Group-centric approach.
Clinical Trial-centric: covers one clinical trial, with the RMS acting as the assessing Member State.
Substance Group-centric: covers clinical trials associated with a Substance Group, with the saMS acting as the assessing Member State.
The ASR Submitter can create, save, edit, and check draft submissions before submission. Supporting documents such as the ASR, SmPC and IB can be uploaded as part of the submission.
Assessment and RFI Process
After submission, the relevant assessing Member State performs the safety assessment. The assessment may include a DAR, comments, Requests for Information (RFIs) and Final Assessment Report (FAR).
The assessment target is 42 days, or 84 days when an RFI is raised. Sponsors normally receive 14 days to respond to an RFI, although the deadline may be shortened.
Finalisation
Once the assessment is completed, the Summary and Conclusions provide the final outcome. This may confirm acceptance, identify follow-up actions and deadlines, or provide recommendations and observations.
The Member State Guidance focuses on how Member State users manage ASR assessments and coordinate safety activities within the new Safety Module.
Member State Roles
The new Safety Module provides different roles for Member State users, including:
ASR Decision Maker Submitter
ASR Assessor
MS Viewer
MS Inspector
These roles provide different levels of access to ASRs, assessments, RFIs, notices and related information.
Selection of the saMS
For multinational Substance Groups, the Safety Module supports the selection of the Substance Group assessing Member State (saMS).
The process includes Member State willingness and expertise, followed by appointment of the final saMS. The guidance provides 12 days for the saMS selection process.
Once appointed, the final saMS takes responsibility for the safety assessment of the relevant Substance Group.
ASR Assessment Workflow
Member State users can access submitted ASRs, assign assessments, and prepare the Draft Assessment Report (DAR).
The assessment workflow includes:
Draft Assessment Report → Comments → Considerations/RFI → Final Assessment Report → Summary and Conclusions
The DAR includes structured questions covering new safety issues, actions taken, updates to previous safety issues, and the benefit-risk assessment. Member States can also select an in-depth or reduced assessment according to the applicable best-practice approach.
RFI and Member State Collaboration
The RFI process supports collaboration between the assessing Member State, other Member States and the sponsor. Member States can provide considerations before the final RFI is submitted to the sponsor. The RFI is managed as a collaborative working document, with one active RFI at a time.
Following the sponsor's response, the assessing Member State can continue the assessment and issue the final assessment outcome.
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