CTIS newsflash – 24 June 2025

23 June 2025 EMA/198062/2025 European Medicines Agency CTIS newsflash – 24 June 2025 Important Update: Changes to the CTIS Newsflash Please be informed that from July 2025, the biweekly CTIS Newsflash will be replaced by the Clinical Trials Highlights Newsletter. For updates on CTIS and other topics related to clinical trials in the EU, we encourage you to subscribe to the Clinical Trials Highlights Newsletter. This newsletter will now be released monthly, offering a more comprehensive overview of clinical trial developments and insights. Subscribe here to stay updated on the evolving clinical trials landscape in the EU. CTIS unplanned downtime On Thursday 26 June 2025, the system will be unavailable between 22:00 to 23:00 CET, in addition to the planned downtime during the regular maintenance window from 18:00 to 21:00 CET. Redesigned sponsor handbook out on 9 July 2025 EMA is redesigning the CTIS training materials for sponsor users, with the aim to improve navigation and ease of use based on stakeholder feedback. A stakeholder focus group, set up under the ACT EU Multi-stakeholder platform, has reviewed and validated the quality of the redesigned materials. The revised sponsor handbook will be published on the EMA website on 9 July 2025, superseding the existing training modules for sponsors. The handbook will serve as the definitive reference for sponsors using CTIS. To support sponsors on the new layout, EMA is also hosting a dedicated...