Drug developers and CROs running trials in the EU have less than a year to transfer details of the program to the EMA’s new system, the Clinical Trials Information System (CTIS).
The Amsterdam-headquartered regulator remained industry about the deadline last week, explaining 31 January 2025 marks the end of a three-year transition period that began when the Clinical Trials Regulation (CTR) became applicable in the European Union (EU).
The agency wrote “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.”
The EMA also suggested sponsors and contract research organizations (CROs) should refer to available guidance, a best practice guide and additional support materials it has put together. The organization has also organized a training event to be held this month.
The CTR was designed to strengthen Europe as an attractive location for clinical research, in part by streamlining the processes for the application and supervision of clinical trials and their public registration.
According to the EMA through the CTIS all 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.”
In the EU, the authorisation and oversight of clinical trials is the responsibility of EU / EEA Member States in which the trial is taking place.
The EMA is responsible for maintaining CTIS. The European Commission oversees the implementation of the CTR.