The ACT EU initiative aims to support the successful and timely implementation of the Clinical Trials Regulation (CTR) and its implementing acts.
This includes:
- tracking the performance of the European clinical trials environment;
- reducing administrative burden while ensuring high levels of transparency;
- regularly consulting sponsors on their experience with the implementation of the CTR and the use of the Clinical Trials Information System (CTIS);
- supporting and guiding commercial and non-commercial sponsors during the transition period of the CTR.
Progress reports on CTR implementation
Under ACT EU, the European medicines regulatory network publishes statistics on the authorisation of clinical trials in the European Union (EU)/European Economic Area (EEA) every month. This information provides an insight into how the CTR is transforming the clinical trial environment in the EU/EEA.
The reports are based on data retrieved from the Clinical Trials Information System (CTIS).
Transitioning trials to the CTR
Clinical trials authorised under the Clinical Trials Directive that are expected to continue beyond 30 January 2025 need to be transitioned to the CTR.
More information and resources to support sponsors are available on the CTIS website.
Transparency in CTIS
The revised CTIS transparency rules become applicable on 18 June 2024, with the launch of a new version of the CTIS public portal.
In the meantime, CTIS users may already follow the principles of the revised CTIS transparency rules for initial clinical trials applications. Further details in the available resources:
- The ACT EU_Q&A on the protection of Commercially Confidential Information and Personal Data while using CTIS which includes section 4 on the interim period until the new transparency rules are in effect and on historical trials;
- The quick guide for users which provides a summary of what will be published when under the revised rules;
- The materials from the CTIS Bitesize talk on the transparency rules.
News
Launch of revised CTIS transparency rules
The revised transparency rules for the Clinical Trials Information System (CTIS) will become applicable on 18 June 2024, with the launch of a new version of the CTIS public portal.
Clinical trials' transition to new EU system - one year left
All ongoing clinical trials in the EU must be transitioned to the Clinical Trials Information System (CTIS) by 31 January 2025.
Revised transparency rules for the EU Clinical Trials Information System (CTIS)
EMA revised rules to give faster access to information in the EU Clinical Trials Information System (CTIS).
Review of transparency rules for the EU Clinical Trials Information System (CTIS)
EMA has opened a public consultation to review the transparency rules for the publication of information on clinical trials submitted through the Clinical Trials Information System (CTIS) in the European Union (EU).
