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Accelerating Clinical Trials in the EU

Implementation of the Clinical Trials Regulation

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.

CTIS website: Transitioning trials

Transparency in CTIS

EMA is working on the technical implementation of the revised CTIS transparency rules.

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:

Related documents

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General publications1 December 2023
Revised CTIS transparency rules, interim period & historical trials: quick guide for users
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(424.91 KB - PDF)
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General publications31 January 2024
Q&A on the protection of commercially confidential information and personal data while using CTIS
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(446.38 KB - PDF)
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General publications24 July 2023
Guidance document on how to approach the protection of personal data and commercially confidential information while using the Clinical Trials Information System (CTIS) Version 1.1
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(951.6 KB - PDF)
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General publications24 July 2023
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 1.1
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(397 KB - PDF)
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General publications24 July 2023
Annex II - Guidance document on how to approach the protection of personal data and commercially confidential information while using the Clinical Trials Information System (CTIS) Version 1.1
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(167.84 KB - PDF)
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General publications26 April 2023
Summary report on targeted consultation on the implementation of the Clinical Trials Regulation (EU) No 536/2014
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(485.38 KB - PDF)
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