The European Medicines Agency (EMA) has published guidance for sponsors on the new Annual Safety Report (ASR) module within the Clinical Trial Information System (CTIS), detailing how to submit ASRs and respond to requests for information (RFIs). The guidance, dated 31 July 2026, is now available in the Sponsor CTIS training environment and is scheduled to be integrated into the CTIS Sponsor Workspace on 28 September 2026.
New Safety Module on the Annual Safety Report" (EMA/178285/2026), provides step-by-step instructions for drafting and submitting ASRs, managing user roles, and handling RFIs raised during the assessment process. It also includes a list of known issues and workarounds in Annex I, and outlines procedures for reporting blocking issues and suggestions to CTIS Support.
Key operational details include the requirement that ASRs can only be submitted for authorised clinical trials, meaning sponsors must first submit and obtain authorisation for new trials within the training environment to practice using the module. The guidance also emphasizes the need for alignment between sponsors and Member States, directing sponsors to contact national contact points for coordination on the training environment.
The new module is part of EMA's ongoing efforts to digitize and streamline clinical trial oversight under the Clinical Trials Regulation (EU) No 536/2014. The transition period arrangements, user role definitions, and the process for exporting lists of clinical trial and safety roles per user are covered in the guidance, ensuring sponsors understand the system's requirements before the module goes live.
For sponsors, the guidance introduces a structured workflow for ASR submission, which is a mandatory annual requirement for authorised trials. The module aims to reduce administrative burden by standardizing the submission process and facilitating electronic communication with assessing Member States. However, the transition to the new system may require additional training and adaptation, particularly for smaller sponsors with limited resources.
Member States will benefit from a more streamlined assessment process, as the module is designed to improve the efficiency of RFI handling and finalisation of ASR assessments. The guidance clarifies the roles of assessing Member States in reviewing ASRs and issuing RFIs, which should lead to more consistent and timely evaluations.
EMA's publication of this guidance marks a preparatory step ahead of the September integration, giving sponsors and Member States time to familiarize themselves with the new module and address any technical issues identified in the training environment. The agency encourages feedback on non-blocking issues and suggestions to refine the system before full deployment.