All you need to know about transition to CTIS
All ongoing clinical trials in the European Union (EU) must be transitioned to the Clinical Trials Information System (CTIS) by 30 January 2025. This date marks the end of a three-year transition period that began when the Clinical Trials Regulation (CTR) became applicable in the EU.
Sponsors of clinical trials under the Clinical Trials Directive expected to continue after 30 January 2025 must consider the time required for Member States to complete the evaluation procedure, which can take up to three months. To help streamline the process, Member States will implement, where possible, an expedited procedure for transitioning trials to the CTR. Ongoing clinical trials do not need to be halted or ended during the transition from the previous legal regime, the Clinical Trials Directive, to the Clinical Trials Regulation.
Learn more about transitional trials from this quick guide for sponsors.
For further information on how to transition your clinical trial, check out the available guidance and training materials.
Transparency in CTIS
The revised CTIS transparency rules became applicable on 18 June 2024, with the launch of a new version of the CTIS website. Support materials and more information are available under Transparency: Questions and Answers.
Searching for clinical trials
This website provides information on individual clinical trials in the European Union and European Economic Area since its launch on 31 January 2022. It will gradually contain more information as clinical trial sponsors and EU/EEA regulators use it to initiate and oversee clinical trials in the EU and EEA.
Information on individual clinical trials initiated in the European Union and the European Economic Area before 31 January 2022 can be found in the European Union Clinical Trials Register.
Transition period
By 31 January 2025, any ongoing trials approved under the Clinical Trials Directive will fall under the Clinical Trials Regulation.
EMA news and events
Find EMA news and events related to clinical trials in the EU and the EEA.
