Website outages and system releases

Users are advised to avoid using CTIS or this website during the regular maintenance windows:

• Tuesdays and Thursdays, from 18:00 to 21:00 Amsterdam time
• Every first Saturday of the month, from 10:00 to 14:00 Amsterdam time

In addition, users are advised to avoid using the CTIS Training environment due to planned downtime for upgrade purposes:

• Every second Friday following a planned release to the Production environment, from 08:30 to 09:30 Amsterdam time

The time zone used in CTIS is Central European Time (CET)/CEST. All due dates and deadlines are displayed in CET/CEST.

If CTIS is unexpectedly down outside of the above downtime windows, users can consult EMA's User support Service landing page for further information, including any deadline extensions for impacted tasks.

A new safety module for the submission and management of annual safety reports is planned to go live on 30 November 2026. To prepare for the go-live, CTIS will be unavailable during the following maintenance periods:

• From Friday, 20 November, at 18:00 CET to Monday, 23 November, at 08:00 CET
• Sunday, 29 November, between 18:00 to 20:00 CET
• Monday, 30 November, between 07:00 to 08:30 CET

To accommodate the planned downtime, deadlines for unanswered requests for information (RFIs) due on Friday, 20 November 2026 will be extended to Monday, 23 November 2026.

Authority users should complete any hard tasks due on Friday 20 November before 18:00 CET. Due dates for hard tasks will not be extended.

The new safety module tab and related role management functionality may be visible to users between 23 November and 30 November 2026 at 08.30 CET. Until the planned go-live date, users attempting to access it will see an error message.

Further information on the new module and related guidance is available in the Clinical Trials Highlights newsletter.