Through the website, members of the public can access detailed information on all clinical trials conducted in the EU, in all official EU languages. The website will provide the following features:
- overview of clinical trial statistics;
- advanced search;
- download data and reports;
- site updates and announcements.
Although the Regulation was adopted and entered into force in 2014, the timing of its application depends on confirmation of full functionality of the EU portal and database through an independent audit. The Regulation becomes applicable six months after the European Commission publishes notice of this confirmation.
EMA’s Management Board endorsed a delivery timeframe in December 2015. However, due to technical difficulties with the development of the IT systems, the portal’s go-live date was postponed.
Update: The development is progressing, though still requires close monitoring. More precision of the delivery timeframe will be possible after a planned cycle of extensive testing by Member States and sponsor representatives and when further progress with the auditable version of the system has been made.
The audit will be carried out in 2018. EMA will provide further information on timelines after the audit.
The development remains aligned to the schedule that enables the EU Clinical TrialRegulation to come into application in the second half of 2019.