The Clinical Trials Information System (CTIS) was launched on 31 January 2022, starting the clock for the three-year transition period from the Clinical Trials Directive to the Clinical Trials Regulation. Since 31 January 2023, it is mandatory for sponsors to submit all initial clinical trial applications via CTIS.

The European Medicines Agency (EMA) is organising this open event to provide:

• reflection on the implementation of the Clinical Trials Regulation;
• reflection on Transitional Trials and Ethics Committee assessment procedures;
• update on the current status of CTIS.