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The European Union Drug Regulating Authorities Clinical Trials (EudraCT) database is the European Medicines Agency (EMA) system for interventional clinical trials on medicines in the European Union (EU) and European Economic Area (EEA). It was established under Directive 2001/20/EC. Since 31 January 2023, initial clinical trial applications in the EU/EEA go through the Clinical Trials Information System (CTIS), but EudraCT remains available for uploading amendments, trial statuses and results of trials already in it.
What EudraCT Is
EMA is responsible for the development, maintenance and coordination of EudraCT on behalf of EU and EEA Member States. National medicines regulators use it for data on clinical trial protocols, and part of that information is published for the public in the EU Clinical Trials Register.
Under the EU Clinical Trials Regulation and CTIS, all initial clinical trial applications in the EU/EEA must be submitted through CTIS from 31 January 2023, and from 31 January 2025 any ongoing trial in the EU/EEA falls under the Clinical Trials Regulation. EudraCT is therefore no longer the route for new European trial applications. It is the record for trials that started under the Directive.
The EudraCT Number
Trials in the database are identified by a EudraCT number. Use the number exactly as issued when searching the EU Clinical Trials Register or when referring to a trial in regulatory correspondence.
Who Runs It and What It Covers
EMA runs EudraCT and manages the EU Clinical Trials Register on behalf of EU and EEA Member States. The Register contains information on interventional clinical trials on medicines. Its scope includes:
- Trials in the EU/EEA: protocol and results information for phase II to phase IV adult trials with investigator sites in the EU/EEA.
- Paediatric trials: trials in children with EU/EEA investigator sites.
- Paediatric investigation plan (PIP) trials outside the EU/EEA: trials conducted exclusively outside the EU/EEA that form part of an agreed PIP, or that fall under Article 46 of the Paediatric Regulation (EC) No 1901/2006, must also be reported.
How to Search or Use It
The public way in is the EU Clinical Trials Register at clinicaltrialsregister.eu, which lets you search the information held in EudraCT. The Register’s own “How to search” document and Home and Search page give the current search options. Sponsors who must upload amendments, statuses or results use EudraCT itself; the EMA clinical trials page explains the arrangements.
Results Posting
Sponsors must post results within 12 months of completing the trial for clinical trials conducted in adults, and within six months for clinical trials in children. As of June 2022, EMA reported 81% of clinical trials compliant with this requirement in EudraCT. For the wider compliance picture, see clinical trial registration and reporting compliance and Good Clinical Practice.
Strengths and Limits
Strengths
- Public access: protocol and results information for phase II to IV adult trials and for paediatric trials is visible in the EU Clinical Trials Register.
- Paediatric coverage: PIP trials conducted outside the EU/EEA are included.
Limits
- Closed to new applications: initial applications in the EU/EEA must be submitted through CTIS.
- Adult phase I: the Register’s description covers phase II to IV adult trials, so adult phase I trials are not among those shown.
- Legacy role: its remaining use is for trials already in it and for the third-country PIP files described above.
Alternatives and Related Registries
| Feature | EudraCT | CTIS |
|---|---|---|
| Operating body | European Medicines Agency (EMA) | European Medicines Agency (EMA) |
| Legal basis | Directive 2001/20/EC | Regulation (EU) No 536/2014 |
| Intake | No new initial applications since 31 January 2023 | All initial applications in the EU/EEA |
| Remaining role | Amendments, statuses and results of trials already in it; third-country PIP files | Submission, assessment and supervision of trials across the EU/EEA |
For registries outside Europe, see ClinicalTrials.gov. Registration timing is covered in prospective clinical trial registration, and trial conduct standards in ICH E6(R3) Good Clinical Practice.
Frequently Asked Questions
What is EudraCT?
The European Union Drug Regulating Authorities Clinical Trials database, run by EMA for EU and EEA Member States.
Can sponsors submit a new clinical trial application through EudraCT?
No. Since 31 January 2023 all initial clinical trial applications in the EU/EEA must be submitted through CTIS.
What happened to ongoing trials on 31 January 2025?
From that date any ongoing trial in the EU/EEA falls under the Clinical Trials Regulation. EudraCT remains available for amendments, statuses and results of trials already in it.
Are adult phase I trials visible in the EU Clinical Trials Register?
The Register shows phase II to phase IV adult trials with EU/EEA investigator sites, plus paediatric trials. Adult phase I trials are not described as viewable.
How soon must results be posted?
Within 12 months of completing the trial for adult trials and within six months for trials in children.
Sources
- European Medicines Agency. Clinical trials in human medicines. https://www.ema.europa.eu/en/human-regulatory-overview/research-development/clinical-trials-human-medicines (checked 2026-11-07)
- European Medicines Agency. Clinical Trials Information System (CTIS). https://www.ema.europa.eu/en/human-regulatory-overview/research-development/clinical-trials-human-medicines/clinical-trials-information-system (checked 2026-11-07)
- EU Clinical Trials Register. About the register. https://www.clinicaltrialsregister.eu/about.html (checked 2026-11-07)
