February 2023: CTIS Newsflash

On February 24, 2023, the European Medicines Agency released the most recent CTIS Newsflash via CTIS.communications. All CTIS newsflash updates are posted on the Development of the Clinical Trials Information System page.

This includes key data and trendsĀ about CTA submissions, CTAs with a decision, and CTAs with a decision per RMS for the week of February 14 to 20, 2023, as compared to the previous week.

On February 20, 2023, a CTIS “Hotfix” was implemented to enable a group of sponsors to modify an application in response to a Request for Information (RFI), by resolving database locks that had occurred in a limited number of trials. Due to the need for additional testing, the next CTIS release will take place the following week implementing all the improvements listed in the previous CTIS newsflash post. For more information, the current version of the release notes andĀ lists of known issues and proposed workarounds can be accessed.

In addition, EMA has initiated the process of registering CTIS as a WHO data provider. Once registered, CTIS data will be accessible on the International Clinical Trials Registry Platform (ICTRP) Search Portal of the WHO.