CTIS newsflash - 22 October 2024

22 October 2024 EMA/469994/2024 European Medicines Agency CTIS newsflash – 22 October 2024 Introduction This regular CTIS newsflash provides key updates on CTIS and links to useful reference materials. The next issue will be circulated on 5 November 2024. Previous issues of the CTIS Newsflash are available on the EMA website. Reminder: Transition ongoing trials from CTD to the Clinical Trials Regulation Sponsors are advised to transition any clinical trial expected to continue after 30 January 2025 from the Clinical Trials Directive (CTD) to the Clinical Trials Regulation (CTR). Sponsors should take into account the time necessary for completion of the Member State(s) evaluation procedure, which can take up to 3 months. Members States have agreed on an expedited procedure for transitioning trials to the CTR which will be applied whenever possible. Sponsors can consult CTCG’s best practice guide on transition, Annex I: Cover letter template, and the newly published Annex II: Fees for transitional trials in EU/EEA Member States. Further resources to support sponsors' transitioning trials are available on the CTIS website. We want your feedback As the end of the CTR transition period approaches, we are inviting stakeholders to share their feedback on events, training materials and communications from EMA that aimed to support them in the implementation of the Clinical Trials Regulation. You can share your views via the survey by 8 November 2024. CTIS...