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 become 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 initially provides limited information on individual clinical trials in the European Union and European Economic Area. It will gradually contain more information as clinical trial sponsors and regulators use it to initiate and oversee clinical trials since the launch of this website and the database underpinning this website, on 31 January 2022.
Clinical trials with a decision issued after mid-August 2022 that have deferrals of any type in the application form are currently not published on CTIS. This is a temporary measure until the functionalities of the public portal are fully restored.
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.
