An overview of the transition periods and requirements
The CTR entered into force on 31 January 2022 and repealed the CTD. During the first year after the CTR entered into force, sponsors could choose whether to apply for a new trial under the CTD, or to apply under the new CTR using the Clinical Trials Information System (CTIS) at the European Medicines Agency (EMA). Since 31 January 2023, all new clinical trial applications must be submitted under the CTR, using the CTIS.
Clinical trials authorized under the CTD that are expected to continue beyond 30 January 2025 will need to transition to the CTR (and the CTIS) before that date. After this date, it will not be possible to continue clinical trials under the old legislation.
The EMA has published several guidance documents to support sponsors in the transition to the CTR, available here.
Who are affected?
Clinical trial sponsors conducting trials in the EU that are expected to continue beyond 30 January 2025 must transition to the CTR before that date. The transition is required for CTD trials with at least one active trial site in the EU after 30 January 2025. If the end of trial is notified in all EU Member States before this date, the transition to CTR is not required, even if the global end of the trial has not been reached yet.
Timeline, updates, and next steps
Although January 2025 is still months away, sponsors should take action in a timely manner. The number of submissions for the transition of trials to the CTR regime is rapidly increasing over the past few months, which may increase the length of the transition procedure. The time required to complete the transition process is currently up to three months.
Our teams regularly provide updates on pharmaceutical developments in the EU. Please contact the authors or the Hogan Lovells attorneys with whom you regularly work for additional information or advice on this matter.
Interested in more details on the transition process? Read our article “Clinical Trials Regulation: Transition your clinical trial now”.
Authored by Milan Tuijp and Hein van den Bos.
