Transparency rules: general information
The CTR (article 81.4) states that the EU database (CTIS) shall be publicly available unless one or more exceptions apply.
Please note! Revised CTIS transparency rules came into effect on 18 June 2024. A document is available with 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.
These exceptions are:
- to protect personal data;
- to protect commercially confidential information, in particular taking into account the marketing authorisation status of the medicinal product, unless there is an overriding public interest in disclosure;
- to protect confidential communication between Member States in preparing their assessment;
- to protect 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.