January 2023: CTIS Newsflash

On January 20, 2023, the European Medicines Agency released the most recent CTIS Newsflash via CTIS.communications.

The next CTIS release that will go live in the week of January 23, 2023, will implement the below key functional improvements:

  • Submission of Part I Disagreement for Substantial Modification (SM) or SM part I and II when Part II was only submitted to the Reporting Member State (RMS) by the Member State Concerned (MSC), even if the RMS had already made a decision regarding the application.
  • Exclusion of the list of conditions from the authorized task from Part II Conclusion of another MSC.
  • Retrieval of the complete list of notifications present in a clinical trial application via Member State Application Programming Interface (API).
  • Improvement in the display of page entries in Member State API.
  • Display the updated information in the “number of subjects” created as a response to a Request for Information (RFI) by clicking on the “Change application” in the authority workspace and Member State API only after submission.
  • Inclusion of only Part I disagreement in the decision section of an Additional Member State application.
  • Calculation of the due date of the Consolidate Considerations and Submit RFI tasks using Central European Time (CET).
  • Functionality improvement of the ‘Pop-up Cancel’ button in the tasks section.
  • Download documents with special characters.

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