EudraCT and the Clinical Trials Information System (CTIS)
EudraCT (European Union Drug Regulating Authorities Clinical Trials Database) is the European database established for interventional clinical trials involving medicinal products conducted under the former Clinical Trials Directive 2001/20/EC.
EudraCT has played an important role in the registration and reporting of clinical trials in the European Union (EU) and European Economic Area (EEA). However, the regulatory framework has now transitioned to the Clinical Trials Regulation (EU) No 536/2014, and the Clinical Trials Information System (CTIS) is the current system for clinical-trial applications in the EU/EEA.
Historical Role of EudraCT
EudraCT covers interventional clinical trials involving medicinal products that were conducted in the EU/EEA between 1 May 2004 and 30 January 2025 under Directive 2001/20/EC.
Under the previous framework, a unique EudraCT number was assigned to a clinical trial and used to identify the trial throughout its regulatory lifecycle.
Information from EudraCT trials has also been made publicly available through the EU Clinical Trials Register.
Transition from EudraCT to CTIS
The Clinical Trials Regulation introduced CTIS as the central system supporting clinical-trial applications and regulatory interactions under the new framework.
Since 31 January 2025, clinical trials continuing in the EU/EEA must comply with Regulation (EU) No 536/2014. New clinical-trial applications and modifications of trials operating under the Regulation are handled through CTIS rather than EudraCT.
CTIS provides a common platform through which sponsors can submit and manage clinical-trial applications and communicate with regulatory authorities across EU/EEA Member States.
Does EudraCT Still Have a Role?
EudraCT has not simply disappeared following the introduction of CTIS. It continues to have limited functions relating to trials conducted under the previous regulatory framework.
Current uses include:
- Submission of results for applicable EudraCT trials.
- Management of certain information associated with historical Directive-era trials.
- Submission of specified information for certain trials conducted exclusively outside the EU/EEA that are associated with a Paediatric Investigation Plan (PIP) or fall within relevant requirements of the Paediatric Regulation.
EudraCT therefore remains relevant for historical clinical-trial information and specific regulatory activities, even though it is no longer the system for submitting new EU/EEA clinical-trial applications.
EudraCT and CTIS
The distinction between the two systems is important:
EudraCT primarily relates to clinical trials conducted under the former Clinical Trials Directive framework and certain continuing reporting or paediatric-related activities.
CTIS is the current system supporting clinical trials conducted under Clinical Trials Regulation (EU) No 536/2014.
Understanding both systems remains useful because historical trials and regulatory records may contain EudraCT numbers and references even though current EU/EEA clinical-trial activities are managed through CTIS.
Importance for Clinical Research Professionals
Clinical research and regulatory professionals may encounter both EudraCT and CTIS when reviewing European clinical-trial documentation.
Knowledge of EudraCT remains important for understanding historical trials and legacy regulatory records, while familiarity with CTIS is essential for clinical trials conducted under the current EU/EEA regulatory framework.
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