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