EMA - Revised CTIS transparency rules will become applicable on 18 June 2024

22nd April 2024

EMA

The revised CTIS transparency rules will become applicable on 18 June 2024, with the launch of a new version of the CTIS public portal. Sponsors are advised to adapt their business processes accordingly.

For all clinical trial applications submitted on or after 18 June 2024:

• it will no longer be possible to defer the publication of data and documents
• data and documents will be published according to established timelines for the trial category, population age and trial phase
• publication of documents will be focused on key documents of interest.

Data on all clinical trial applications submitted before 18 June 2024 will be made publicly available in line with the principles and timelines defined in the revised transparency rules. Please note that documents of these trials will not be published. Documents contained in subsequent applications of these trials, submitted after 18 June 2024 will be published in line with the revised rules*; more details are available in the quick guide for users.

In the interim period until 18 June 2024, sponsors may already follow the principles of the revised CTIS transparency rules.

Useful materials for sponsors

• For an overview of what will be published when, including details on the disclosure of information on trials submitted before 18 June 2024, please refer to the quick guide for users
• The CTIS Bitesize talk on the transparency rules provides an overview of the changes in CTIS
• A follow-up CTIS Bitesize talk on the topic is planned on 20 June 2024, to further support sponsors in adapting their business processes accordingly.

More information is available on the ACT EU website: Launch of revised CTIS transparency rules

* This applies to documents of all types of applications, with the exception of part I documents of Non Substantial Modifications and Additional Member State applications.

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