All trial sponsors must submit applications through the bloc’s common portal
A new online system for requesting approval to conduct a clinical trial in the EU has now become mandatory.
In the past, sponsors of trials that were proposed to take place in the bloc had to submit applications to individual national authorities and ethics committees to gain regulatory approval to proceed.
The new Clinical Trials Information System, which from 31 January must be used for new applications, will simultaneously grant authorisation in up to 30 countries in the bloc or European Economic Area, without additional documentation.
Its introduction follows a year-long transition period in which sponsors could choose between applying for approval under the legacy Clinical Trials Directive or its replacement, the Clinical Trials Regulation, which introduced the CTIS.
Sponsors have until the end of January 2025 to transfer any ongoing trials approved under the Clinical Trials Directive to the new application system.
The European Medicines Agency said that the application of the Clinical Trials Regulation “strengthens Europe as an attractive location for clinical research”.
It added that the regulation “streamlines the processes for the application and supervision of clinical trials”.