Publication of clinical trial information

Clinical trials authorised under the Clinical Trials Directive (CTD)

Sponsors are required to make a summary of the results of concluded clinical trials publicly available in the EU clinical trials database (EudraCT) .

For further information, please see the EMA website and:

• letter from the European Commission (EC), the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) this requirement.  
• and press release
• additional information and guidance on reporting trial results to EudraCT.

All trials authorised under the CTD must end or transition to the CTR by 30 January 2025.

Clinical trials authorised under the Clinical Trials Regulation (CTR)

The CTR aims to increase transparency and the availability of information on clinical trials through the publicly accessible section of CTIS (Clinical Trials Information System).  The ‘advanced criteria’ search function can be used to search for ongoing clinical trials in Ireland.

For information on transparency requirements and justifiable exemptions (e.g. personal and proprietary data), see European Commission's Questions and Answers Guide on the CTR, Volume 10.