The CTR (article 81.4) states that the EU database (CTIS) shall be publicly available unless one or more exceptions apply.
These exceptions are to protect personal data, commercially confidential information, confidential communication between Member States, and the supervision of clinical trials by Member States. More information on CTIS transparency rules can be found in the guidance and Q&As section on the CTIS website, and in section 2.1 of the CTIS Sponsor Handbook of EMA.
The current transparency rules apply since the revision of 18 June 2024. Please also refer to the document frequently asked questions on CTIS transparency rules. For an overview of what information will be published in CTIS at what time, a quick guide for users on the revised CTIS transparency rules has been published. It contains important information about the impact of the revised transparency rules on studies submitted to CTIS before 18 June 2024.