|Hosted on behalf of the European Commission|
|EudraCT user manual|
|Registering a trial and updating its information|
|EudraCT number, CTA & Login for posting results|
|CTA & results documentation|
|Tutorials on posting results|
|Frequently asked questions|
|National competent authorities|
|Statistics and technical documentation|
|EU Clinical Trials Register|
|Need Help? Contact us|
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 are reminded that, whenever possible, the contact point specified in section B.5.6 of the Clinical Trial Application should give functional information rather than details of one "person", in order to avoid the need for update and maintenance of these contact details.
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
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.
The EMA will be closed for public holidays from 23/12/2021 to 03/01/2022. Please note: any question submitted to the Service Desk as well as requests sent after 21/12/2021 for assignment as a primary user to post results will be processed from the 04/01/2022.
EudraCT application maintenance weekend 25-26 September 2021
Essential maintenance is scheduled to be carried out to SPOR data services between 18:00 on Friday 24th September and 20:00 on Sunday 26th September 2021, as a consequence some functionalities of the EudraCT website may not work during this timeframe. We apologise for this inconvenience and we thank you very much for your patience.
EudraCT and EU CTR application maintenance weekend 19-20 June 2021
The Agency will be performing essential maintenance to IT infrastructure components during the weekend of 18th to 20th June. As a result, EudraCT and EU CTR will be unavailable to users between 18:30 hrs. on Friday, 18th June and 23:59 hrs. on Sunday, 20th June 2021. We apologise for this inconvenience and we thank you very much for your patience.
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.
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.
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.
From January 1st, 2021, for all clinical trials recorded in EudraCT that are ongoing in the EU/EEA:
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.
In addition, from January 1st, 2021 sponsors will be able to perform the following changes in the CTA:
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.
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.
The statistics for October 2020 are now available.
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.
The statistics for September 2020 are now available.
Sponsors of trials that are "prematurely ended" can now post results in EudraCT as a 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).
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.
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.
Computer application maintenance weekend 19-20 September 2020
The statistics for August 2020 are now available.
The statistics for July 2020 are now available.
The Joint Technical Notice to Sponsors by the European Commission, EMA and HMA was published yesterday on the European Commission health website.
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.
The statistics for June 2020 are now available.
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.