Publication of clinical trial information
Clinical trials authorised under the Clinical Trials Directive (CTD)
The European Commission (EC), the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have co-signed a letter reminding all sponsors of clinical trials conducted in the European Union of their obligation to make summaries of results of concluded trials publicly available in the EU Clinical Trials Database (EudraCT)
The letter and a supporting press release are available from the EMA website.
We would encourage clinical trial sponsors in Ireland to visit the EMA website to access this information. There are additional links to materials and tools which are available to stakeholders in order to provide them with information and guidance on reporting trial results to EudraCT.
All trials authorised under the CTD must end or transition to the CTR by 31 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).
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.