Welcome to EudraCT
As of 31 January 2025, the conduction of trials in the EU/EEA is no longer allowed under Directive 2001/20/EC and should be performed under Regulation (EU) 536/2014 only. Submissions of new clinical trial applications must be performed through the Clinical Trial Information System, as well as submissions of modifications of existing CTIS applications. Please see CTIS: how to get started.
Please find below an overview of the actions that can still be performed through EudraCT. Specific instructions are provided in the EudraCT User manual and Step-by-step guide.
Create a EudraCT number for a third-country file
As of 31 January 2025, EudraCT only allows the creation of new EudraCT numbers for trials conducted exclusively outside of the EU/EEA that are part of a Paediatric Investigation Plan (PIP) and/or in scope of Article 46 of the Paediatric Regulation (EC) 1901/2006 (so called "third country file").
With regards to PIP/Art 46 trials that are going to be conducted within the EU/EEA, and for PIP/Art 46 trials that are going to be conducted both in the EU/EEA and in third countries, a single application must be submitted through the Clinical Trials Information System.
Information on Clinical Trial Protocols
Third-country data providers
can continue to use the EudraCT database to create and post a third country XML file. Please note that a sponsor user should request the Third Country Data Provider role to be added to their EMA-account prior to posting. This can be requested via the EMA ServiceNow. Please refer to the FAQ for more information.
Please note that EudraCT is an application for the creation/amendment of third-country XML files. Those files are not saved in EudraCT. To retain information, the sponsor must actively download and save those XML files on a local drive.
Results related information
Sponsors
are responsible for posting their EudraCT trials' results through logging in EudraCT, through requesting to become the primary user for their trials: see Tutorials on posting results for detailed instructions. Once a trial assigned to a primary user, it is possible to:
- nominate backup user for their trials.
- create or load locally saved EudraCT results XML files in order to edit, validate and post them as a "full data set".
- upload and post a "summary attachment" with (partial) results of a trial, or with a justification of missing results for a prematurely ended trial.
The Frequently Asked Questions document clarifies under which conditions results must be posted as a "full data set" and in which cases a "summary attachment" suffices. It also provides answers to the most common issues a sponsor may encounter throughout this process.
