February 2023: CTIS Newsflash

On February 03, 2023, the European Medicines Agency released the most recent CTIS Newsflash via CTIS.communications.

Starting on January 31, 2023, sponsors can no longer submit initial EU/EEA Clinical Trial Applications under the Clinical Trials Directive. All initial clinical trial applications in the EU/EEA must be submitted through CTIS.

The EudraCT website has been updated accordingly and is, therefore, to be used only for the purposes of:

  • Updating information like CTA amendments, status updates, and results submission on EudraCT trials submitted under the Directive (until January 30, 2023)
  • Creating and submitting third-country files of Paediatric Investigation Plans (PIP)/Art 46 trials conducted exclusively in third countries (outside of the EU/EEA)

On February 01, 2023, a CTIS release went public that included the following functional upgrades:

  • When responding to RFIs, documents submitted by sponsors will now be instantly saved in the system, allowing a user from the same organization who has the right roles and rights to see the modifications in drafts.
  • Following the submission of a non-substantive amendment, sponsors can submit the trial period notifications.
  • Following a Substantial or Non-Substantial Modification, updated clinical trial titles will be properly listed in the Sponsor and Authority Workspace as well as the Public Portal.
  • Sponsors with a CT admin-specific trial will be able to assign roles to another user for the trials in their scope.
  • Due to slow response times, users won’t be automatically logged out when experiencing internal server errors.

More information can be found in the current version of the release notes and lists of known issues and proposed workarounds.