Use of Clinical Trials Information System becomes mandatory for new clinical trial applications in the EU
10. Februar 2023 – From 31 January 2023, all initial clinical trial applications in the EU must be submitted via the Clinical Trials Information System (CTIS). With CTIS, it is now possible to apply for authorisation in up to 30 EU/EEA countries at the same time and with the same documentation. The new Clinical Trials Regulation (CTR) streamlines the processes for the application and supervision of clinical trials, and their public registration.
For more information, see here.