Welcome to the EudraCT public home page

EudraCT (European Union Drug Regulating Authorities Clinical Trials Database) is the European database for all interventional clinical trials on medicinal products authorized in the European Union (EEA) and outside the EU/EEA if they are part of a Paediatric Investigation Plan (PIP) from 1 May 2004 onwards. It has been established in accordance with Directive 2001/20/EC. Protocol and results information on interventional clinical trials are made publicly available through the European Union Clinical Trials Register since September 2011.

In order to navigate through the present website, it is strongly encouraged to refer to the EudraCT user manual.

Sponsors’ representatives are recommended to prepare and post clinical trials results as explained in the Tutorials on posting results webpage.

Requirements to provide results for authorised clinical trials: Joint Letter by the European Commission, EMA and HMA

What's New

Previous news can be found here

16-09-2019

Weekend maintenance to most EMA computer applications during the weekend of 21st – 22nd September 2019.

Users should be aware that due to essential maintenance work on Oracle databases, most of EMA’s computer applications will experience downtime between the hours of 18.00 on Friday, 20 September and 06.00 on Monday, 23 September 2019.

If you have any questions, please contact the IT service desk.

29-08-2019

EudraCT CTA - 10.3.1.0- Release notes are now available here.

22-08-2019

New updates on the EudraCT website:

• A new page Tutorials on posting results will help users to prepare/post results.
• The EudraCT user manual (formerly “Help”) is more visible to users.
• The side menu and the homepage are now easier to navigate.

06-08-2019

An amended template for requesting assignment for results is now available, and can be found here.

05-08-2019

EudraCT statistics for the month of July 2019 are now available here.

26-07-2019

As of 26 July 2019, a new process for registering a new/development substance in EudraCT will be in place. This means instead of creating development substances directly in xEVMPD, Sponsors of CT will need to request them in advance if they want to submit a clinical trial application in EudraCT, or an Investigational Medicinal Product in XEVMPD.

Requests will need to be made using the EMA Service desk portal. If you are already registered, open your request here:
https://servicedesk.ema.europa.eu/jira/servicedesk/customer/portals

If you are not registered, register using the EMA Service desk portal:
https://register.ema.europa.eu/identityiq/login.jsf?prompt=true

In the request you must attach:

• Completed Substance request form
• Supporting documentation for the substance (e.g. SmPC or Investigators’ brochure)

This is not a new process but is now extended to the registration of substances for clinical trials.
Note that this process can take 4 working days, so users need to take the SLA into consideration when planning the submission of their applications.

03-07-2019

Requirements to provide results for authorised clinical trials: Joint Letter by the European Commission, EMA and HMA

02-07-2019

EudraCT statistics for the month of June 2019 are now available here.