Article
CRO · Regulation · 9 October 2024
The Clinical Trials Regulation, Regulation (EU) No 536/2014, has applied since 31 January 2022. It replaced the Clinical Trials Directive with one set of rules for the authorisation and supervision of clinical trials across the European Union and the European Economic Area.
Its three-year transition period ended on 30 January 2025. Since 31 January 2025 only the Regulation applies: trials authorised under the Directive that continued beyond that date had to be transitioned to it.
The Clinical Trials Information System (CTIS), run by the European Medicines Agency, is the single platform through which sponsors submit applications and member states assess and supervise trials. Its use became mandatory for new applications on 31 January 2023.
According to the agency's annual report for 2025, 5,088 clinical trials were moved from EudraCT to CTIS during the transition.
For sponsors, one application now covers every member state concerned, with a coordinated assessment and common timelines.
Sources: European Medicines Agency — Clinical trials' transition to new EU system · European Medicines Agency — Use of CTIS becomes mandatory for new clinical trial applications · European Medicines Agency — Annual report 2025, human medicines
