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 on CTR implementation
Under ACT EU, the European medicines regulatory network (EMRN) 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).
Implementation progress reports
Targeted surveys collect feedback from clinical trial sponsors on their experience with the implementation of the CTR and the use of CTIS.
A summary report on the 2023 survey is now available.
A summary report on the 2022 survey is also available:
Report on the 2022 survey on the implementation of the Clinical Trials Regulation.
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 became applicable on 18 June 2024, with the launch of a new version of the CTIS public portal.
Additional materials are available to support sponsors in the implementation of the revised rules:
- The quick guide for users which provides a summary of what will be published when under the revised rules;
- The Guidance document on how to approach the protection of personal data and commercially confidential information while using CTIS and Annex I which provides an overview of the types of data and documents submitted to CTIS that are subject to publication;
- The Q&A on the protection of commercially confidential information and personal data while using CTIS;
- The materials from the CTIS Bitesize talk on the revised transparency rules on 20 June 2024.
News
The enhanced portal aims to benefit the public by making it easier to search for publicly available information on clinical trials in the EU and EEA.
Revised rules for Clinical Trials Information System (CTIS) become applicable.
Pilots are part of ACT EU collaboration to foster high-quality clinical research in the EU.
