January 2023: CTIS Newsflash

On January 13, 2023, the European Medicines Agency posted the most recent CTIS newsflash to the What’s new section.

On January 12, 2023, a CTIS release went public that included the following functional upgrades:

  • Improved submission of an application to add a new Member State Concerned (MSC)
  • Sponsors can now include or exclude the Proof of Payment in all phases of evaluation when responding to an RFI.
  • Sponsors can now change an application that is part of the response to an RFI raised in the context of an Additional Member State Concerned application or Substantial Modification.
  • Sponsors will be not able to submit an initial application without a valid EudraCT number.
  • Sponsor users will not receive a validation error message while working parallelly in the IMPD-Q and Safety & Efficacy placeholders ensuring only documents or a justification is included in both.
  • Member States can now retrieve all trial site information and the complete list of age range via the Member State API.
  • Member States Concerned now receive the notices “RFI sent to sponsor”, “Consolidated consideration shared” and “Response to RFI submitted”, in case of submission of partial initial applications (part I only).
  • ­Member State users can now select all considerations, consolidated considerations, and RFI, regardless of the number of pages required to list them.

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

Additionally, the event page has been updated with a video of the November 23, 2022, CTIS bitesize talk: Notifications, Part 2.