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EU: EU Clinical Trials Regulation and new Information System finally in place

Blog-News aus Europa

As of 31 January 2022, the new Clinical Trials Regulation (EU) No. 536/2014 (CTR) entered into force, repealing the Clinical Trial Directive (EC) No. 2001/20/EC. This step is meant to facilitate the daily business of sponsors in the EU immensely, when it comes to filing clinical trial applications. The new Clinical Trials Information System (CTIS) serves as a single-entry point for submission and assessment of clinical trial data for all EU and EEA countries and has gone live.

What’s new?

In the past, sponsors had to submit clinical trial applications separately to national competent authorities (NCAs) and ethics committees in each European country to gain regulatory approval. To run a clinical trial, and registration and posting of results were also separate processes. With the new Clinical Trials Information System /CTIS), sponsors can now apply for authorisations in up to 30 EU/EEA countries at the same time and with the same documentation. Publication of the trial information is built in the system. This should strengthen Europe’s position as an attractive location for clinical research and enhance transparency on outcomes of authorised clinical trials.It also has an impact on Annex 13 of the EU GMP Guide, which will be replaced by the new regulation.

What’s the timeline?

  • The CTR foresees a three-year transition period.
  • Member States will work in CTIS immediately after the system has gone live.
  • Until 31 January 2023, clinical trial sponsors can still choose whether to submit an initial clinical trial application in line with the Clinical Trials Directive (EC) No. 2001/20/EC or via CTIS.
  • From 31 January 2023, submission of initial clinical trial applications via CTIS becomes mandatory.
  • By 31 January 2025, all ongoing trials approved under the current Clinical Trials Directive will be governed by the new Regulation and must be transitioned to CTIS.

Along with this EMA has published a comprehensive Q&A on the new regulation, as well as various descriptive material and You Tube videos on the subject.


EC: Regulation (EU) 536/2014

EMA: Clinical Trials Information System

EMA: Clinical Trials Regulation