The Clinical Trials Information System (CTIS) was launched on 31 January 2022, starting the clock for one-year transition period for all sponsors of clinical trials. During the transition period, clinical trial sponsors can choose whether to submit an initial clinical trial application in line with the Clinical Trials Directive or under the Clinical Trials Regulation (CTR), via CTIS. Starting from 31 January 2023, the use of CTIS will be mandatory for all initial clinical trial application in the European Union (EU). The European Medicines Agency is offering this open event to provide:
- reflection on the implementation of the Clinical Trials Regulation;
- update on the current status of CTIS;
- outlook on 2023/2024 CTIS planning.