On January 6, 2023, the European Medicines Agency released the most recent CTIS Newsflash via CTIS.communications.
On December 22, 2022, a CTIS ‘Hotfix’ went live, and by January 05, 2023, following improvements will be implemented:
- Documents will not be inadvertently removed from the original clinical trial application after these are deleted in a copied clinical trial application.
- Sponsor will be able to submit a response to an RFI with a change application without losing documents in Part I.
More information can be found in the current version of the release notes and list of known issues and proposed workarounds.