Since the start of 2025, there is only one way to run a clinical trial in the EU. The Clinical Trials Regulation and its portal, CTIS, are now the whole game — and sponsors who treated the transition as optional have felt it.
Regulation (EU) 536/2014 has applied since 31 January 2022, replacing the old Clinical Trials Directive. Its defining feature is a single application dossier assessed in a coordinated way across all Member States concerned, submitted through one system.
The transition is over
The three-year transition closed on 31 January 2025. Every trial still ongoing that had been approved under the old Directive had to be transitioned to the Regulation and CTIS by that date. The Clinical Trials Information System (CTIS) is now the sole entry point — the legacy route is closed to new submissions.
How CTIS works
One submission serves all concerned Member States. Assessment is split into Part I (scientific and product aspects, assessed jointly under a Reporting Member State) and Part II (national and ethical aspects, assessed by each Member State). The model trades a steeper learning curve for a genuinely harmonised authorisation.
Transparency you must plan for
Revised transparency rules that took effect in mid-2024 simplified the framework and, crucially, removed the long deferral mechanism that previously allowed publication to be delayed for years. Sponsors now work with a reduced set of structured data and documents made public, balanced against commercially confidential information and personal data — but the default is disclosure. Build your documents with publication in mind from the start.
A maturing system
CTIS continues to receive usability improvements, guided by the joint EMA, Commission and HMA initiative Accelerating Clinical Trials in the EU (ACT EU) and its ongoing workplan. The direction is toward smoother multinational trials, not away from them.
How PQRA helps
PQRA supports CTIS submissions, dossier preparation and lifecycle management for clinical trials in Greece and across the EU.
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