EU’s CTIS Set for Takeoff at End of January 2022
All systems are go for the EU’s Clinical Trials Information System (CTIS), with the European Commission disclosing that the IT technology platform will be launched as planned on Jan. 31.
The launch of the CTIS will bring the long-awaited Clinical Trials Regulation (CTR) into effect. Multiple technical problems had repeatedly pushed back the launch of the CTIS, and consequently the CTR, but it now appears that those have been ironed out.
Under the EU’s revamped clinical trial regulations, which will replace the current Clinical Trials Directive, the CTIS must be used for new clinical trials starting Jan. 31, 2023, meaning there will be a year’s time in which trial applicants still have the option of submitting their trial applications via the current system.
As of Jan. 31, 2025, all ongoing trials approved under the EU’s current trial requirements will be required to transition to the CTR, the commission said. To help prepare applicants prior to launch, the European Medicines Agency has posted training resources online that detail how to use the new system.
The CTIS will serve as the sole gateway for trial application submission, authorization and monitoring in the EU, as well as Iceland, Liechtenstein and Norway, which are members of the European Economic Area, the commission said. Currently, sponsors must submit their trial applications separately to national competent authorities and ethics committees in each country in order to be approved to conduct a trial.