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

Brexit preparedness: Joint Technical Notice to Sponsors by the European Commission, EMA and HMA and Notice to stakeholders of 7 May 2020

What's New

Sponsors of clinical trials on COVID-19 are requested to include the term "COVID-19" in the title of their trial (section A.3 of the CTA). Sponsors are also reminded of the importance of timely reporting of SAEs (Serious Adverse Events) and of SUSARs (Suspected Unexpected Serious Adverse Reactions) to the competent authorities, in order to protect the safety of the participants. In addition, we encourage sponsors of COVID-19 trials to post the relevant results as soon as it is feasible, also before the deadline.

16-02-2021

EudraCT and EU CTR application maintenance weekend 20-21 February 2021

Essential maintenance work will be carried out to EudraCT application and EU CTR. As a result, the websites will be unavailable to users between 18:30 hrs. on Friday, 19th February and 08:00hrs on Monday, 22nd February 2021. We apologize for this inconvenience and we thank you very much for your patience.

09-02-2021

EudraCT and EU CTR application maintenance weekend 13-14 February 2021

Essential maintenance work will be carried out to EudraCT application and EU CTR. As a result, the websites will be unavailable to users between 18:30 hrs. on Friday, 12th February and 08:00hrs on Monday, 15th February 2021. We apologize for this inconvenience and we thank you very much for your patience.

17-12-2020

The EMA will be closed from 23/12/2020 to 03/01/2021. Please note: Requests sent after 21/12/2020 for assignment as a primary user to post results and for EudraCT/EU CTR related queries will be processed after the 03/01/2021.

07-12-2020

From January 1st, 2021, for all clinical trials recorded in EudraCT that are ongoing in the EU/EEA:

1. Sponsors established in the United Kingdom prior to 31 Dec 2020, must as of 1 January 2021 be legally established in the EU/EEA or have a Legal representative who is legally established in the EU/EEA.
2. Legal representatives established in the United Kingdom prior to 31 December 2020 can no longer act as a legal representative of a UK sponsor as of 1 January 2021.
3. Qualified persons established in the United Kingdom other than in Northern Ireland can no longer certify batch-release of an IMP for use in EU/EEA as of 1 January 2021 and must be established either in the EU/EEA or in Northern Ireland.

Sponsors are requested to update these requirements in sections B.1, B.2 and/or D.9.2 of the Clinical Trial Application (CTA) form, as appropriate, using the EudraCT application (click on “EudraCT number, CTA & Login for posting results”, then “load -> EEA CTA”, add the CTA XML file, perform the changes and save the CTA file locally). The amended XML file of the CTA will then need to be submitted to all the relevant National Competent Authorities where the trial is submitted/ongoing.
Please note that it is already possible for sponsors to modify the XML file of their CTAs with the following:

• Update section B.1 with a sponsor based in EU/EEA
• Update section B.2 with a EU/EEA legal representative for third country sponsors having a legal representative based in UK
• Update section D.9 with a Qualified Person based in EU/EEA

In addition, from January 1st, 2021 sponsors will be able to perform the following changes in the CTA:

• Update section B.2 with a EU/EEA legal representative, for trials with sponsors based in UK
• Update section D.9.2.4.4 specifying “Northern Ireland” in the country field

26-11-2020

EudraCT and EU CTR application maintenance weekend 28-29 November 2020

Essential maintenance work will be carried out to EudraCT application and EU CTR. As a result, the websites will be unavailable to users between 18:30 hrs. on Friday, 27th November and 08:00hrs on Monday, 30th November 2020. We apologise for this inconvenience and we thank you very much for your patience.

24-11-2020

The Frequently Asked Questions document has been completely revised. Sponsors are encouraged to refer to it for questions on EudraCT/EU CTR. Comments and suggestions on the document are also welcome, to be sent via the Service Desk.

The Service Level Agreement for the addition of a new active substance in EudraCT has changed. Now it could take 5-10 days to have a substance added in section D. of the Clinical Trial Application form. The process is described in the Frequently Asked Questions.

09-11-2020

The statistics for October 2020 are now available.

19-10-2020

Update: The below issue is now resolved.

We would like to make Sponsors aware there is an issue with the assignment of primary users of trials, as well as with the activation of results user roles in EudraCT.
Our IT is working to fix it as soon as possible. We thank you very much for your patience and we apologise for the inconvenience.

16-10-2020

In order to receive assistance with your EMA account, enable it again or recover a username / password, please refer to EMA Account Management.

08-10-2020

The release notes for EudraCT version number 10.5.0.0 are now available in the Technical documentation section.

06-10-2020

The statistics for September 2020 are now available.

1-10-2020

Sponsors of trials that are "prematurely ended" can now post results in EudraCT as a pdf document.

• For trials that were approved but never started, sponsors are required to state the reasons for the premature interruption in the pdf document

• For trials that started and terminated early, sponsors are required to state the reasons for the early interruption, together with any partial result, if available, in the pdf document

Please refer to the Tutorials on posting results in order to know how to become a primary user for your trial and post the pdf document. After the document has been uploaded, kindly click on "post results" on the top right corner. The document will be published in EU CTR after 2 weeks from posting date (except for phase 1 trials in adults, that are not publicly available, see FAQs).

30-09-2020

The EudraCT website will be unavailable to users today between 6 pm and 8 pm (CET). We apologise for this inconvenience and we thank you very much for your patience.

28-09-2020

A new version of the document "Results: modalities and timing of posting" is now available. This document provides more clarity regarding the modality of results posting for trials ended before 21 July 2013 and between 21 July 2013 and 21 July 2014.

16-09-2020

Computer application maintenance weekend 19-20 September 2020

Essential maintenance work will be carried out to all EMA Telematics applications. As a result, the EudraCT website will be unavailable to users between 18:30 hrs on Friday, 18th September and 08:00hrs on Monday, 21th September 2020. We apologise for this inconvenience and we thank you very much for your patience.

02-09-2020

The statistics for August 2020 are now available.

04-08-2020

The statistics for July 2020 are now available.

10-07-2020

The Joint Technical Notice to Sponsors by the European Commission, EMA and HMA was published yesterday on the European Commission health website.

08-07-2020

Computer application maintenance Saturday, 11 July 2020

Essential maintenance work will be carried out to all EudraCT applications as part of EMA’s computer application maintenance work this weekend. As a result, EudraCT systems will be intermittently unavailable between 10:00hrs and 13:00hrs of Saturday, 11 July 2020. If you have any questions, please contact the EMA Service Desk.

06-07-2020

The statistics for June 2020 are now available.

And

The frequently asked questions have been updated.

Previous news can be found here

For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.