January 2023: CTIS Newsflash

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.