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Accelerating Clinical Trials in the EU

Implementation of the Clinical Trials Regulation

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. 

4 JULY 2024
Report on the 2023 survey on the implementation of the Clinical Trials Regulation

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.

CTIS website: Transitioning trials

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:

Related documents

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General publications8 July 2024
Revised CTIS transparency rules & historical trials: quick guide for users
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General publications18 June 2024
Guidance document on how to approach the protection of personal data and commercially confidential information while using the Clinical Trials Information System (CTIS) Version 2
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General publications18 June 2024
Annex I - Guidance document on how to approach the protection of personal data and commercially confidential information while using the Clinical Trials Information System (CTIS) Version 2
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General publications8 July 2024
Q&A on the protection of commercially confidential information and personal data while using CTIS
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General publications4 July 2024
Report on the 2023 survey on the implementation of the Clinical Trials Regulation
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General publications26 April 2023
Report on the 2022 survey on the implementation of the Clinical Trials Regulation

News

  • News article

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.

  • 1 min read