All ongoing clinical trials in the EU must be transitioned to the Clinical Trials Information System (CTIS) by 31 January 2025. This date marks the end of a three-year transition period that began when the Clinical Trials Regulation (CTR) became applicable in the EU.
Sponsors of clinical trials expected to continue after 30 January 2025 must consider the time required for Member States to complete the authorisation procedure, which can take up to three months. To help streamline the process, Member States will implement, where possible, an expedited procedure for transitioning trials to the CTR. Ongoing clinical trials do not need to be halted or ended during the transition from the previous legal regime, the Clinical Trials Directive (CTD), to the Clinical Trials Regulation.
To help sponsors make the transition, there is guidance available, a best practice guide for sponsors of multinational clinical trials, and additional support materials. Dedicated training activities are also being organised, starting with an event for academia on 9 February.
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.