The European Medicines Agency (EMA) has published guidance for member states on the new safety module for the Annual Safety Report (ASR) within the Clinical Trial Information System (CTIS), which is set to be integrated into the CTIS Member State Workspace on 28 September 2026. The guidance, dated 31 July 2026, details the assessment procedures, user roles, and submission modalities under the new module, which is currently available in the Member State CTIS training environment.
The document outlines the transition period arrangements, user roles and role matrix, and the process for selecting the single assessing Member State (saMS) for substance group-centric ASRs. It includes instructions on how member states can access the training environment, requiring them to also take on sponsor roles to submit clinical trials and ASRs for training purposes. The guidance also covers the assessment workflow, including downloading and assessing ASRs, and provides a list of known issues and workarounds in Annex I.
This guidance is part of EMA's ongoing efforts to enhance the safety reporting process within CTIS, which was launched in January 2022 to streamline clinical trial applications and oversight across the EU. The new safety module aims to improve the efficiency and consistency of annual safety report assessments by centralizing the process and clarifying the roles of member states. The integration into the live CTIS workspace on 28 September 2026 will mark a significant step in the digital transformation of clinical trial oversight in the EU.
Stakeholders, including national competent authorities and sponsors, will need to adapt to the new module, which may require additional training and adjustments to internal processes. The guidance provides detailed instructions to facilitate a smooth transition, but the new system could initially increase administrative burden for member states as they familiarize themselves with the new workflows. However, the centralized approach is expected to reduce duplication of effort and improve the quality of safety assessments in the long term.
EMA has also established support mechanisms, including a master trainer system for reporting blocking issues and feedback, to assist member states during the transition. The agency encourages member states to report any issues encountered in the training environment to ensure the module is fully functional before its official integration.