Transition of clinical trials to the Clinical Trials Regulation New

Transition of clinical trials of medicinal products - the countdown is on!

All ongoing clinical trials in the EU need to be converted to the Clinical Trials Information System ("CTIS") in accordance with Regulation (EU) 536/2014 ("CTR") by January 31, 2025. This date marks the end of a three-year transition period that began when the CTR came into force in the EU.

Clinical trials of medicinal products that are not converted by the sponsor in time lose their legal basis and will have to be terminated by the National authority.

Transition procedure

The transition to the CTR requires its own approval procedure to be carried out via CTIS. Once this procedure has been completed, the clinical trial will then be subject to the CTR in terms of the rules governing its conduct.

Ongoing clinical trials do not have to be halted or terminated during the transition from the previous legal framework of the Clinical Trials Directive (CTD) to the CTR.

However, sponsors of clinical trials that are to continue after January 30, 2025, should take into account the time required by Member States to complete the approval process, which can take up to three months.

In order to streamline the process, Member States have introduced a voluntary expedited procedure for transitioning trials to the CTR. This expedited procedure cannot be guaranteed in the final phase of the transition period.

Guidelines and training material

To facilitate the transition for sponsors, guidelines, a "Best Practice for Sponsors of Multinational Clinical Trials" and additional training materials are available. The European Medicines Agency also organizes training courses that are available online.

About Regulation (EU) 536/2014

The application of the CTR strengthens Europe as an attractive location for clinical research. The regulation streamlines the processes for the application and supervision of clinical trials, and their public registration: all clinical trial sponsors use the same system and follow the same procedures to apply for the authorisation of a clinical trial, no matter where they are located and which national competent authority (NCA) or national ethics committee they are dealing with.

The authorisation and oversight of clinical trials is the responsibility of EU / EEA Member States while the European Medicines Agency is responsible for maintaining CTIS. The European Commission oversees the implementation of the Clinical Trials Regulation.


Further inquiry note