February 2023: Clinical Trials Highlights

On February 20, 2023, EMA published the thirteenth issue of the Clinical Trials Highlights. All Clinical Trials Highlights updates are posted on the Development of the Clinical Trials Information System page.

Starting from January 31, 2023, sponsors are required to submit their initial clinical trial applications through CTIS. EMA has resolved a considerable number of issues, improving the user experience and providing system enhancements by strengthening the notices and alerts functionality, enhancing the creation and preparation of application documents and data, and enhancing the authorization and supervision of clinical trials.

The CTIS User Support Service has been strengthened to address user inquiries effectively, and the steps to raise a ticket are provided. Additionally, EMA issues a weekly CTIS Newsflash that includes significant updates on new releases and system developments, reminders about upcoming training and events, and links to helpful reference material.

The upcoming CTIS events include the sponsor end-user training programs scheduled on May 02 to 05, 2023, and June 27 to 30, 2023.