CTIS and Clinical Trials Regulation updates

Published: July 15, 2026

Several important updates have recently been introduced for sponsors using the Clinical Trials Information System (CTIS) and conducting clinical trials under the Clinical Trials Regulation (CTR).

New CTIS email notifications

A new CTIS feature allows users to opt in to receive notices and alerts by email, helping users stay informed without having to log into the system. Organisations are encouraged to agree internally which users should enable this feature to ensure key notifications are monitored. Guidance is available in Section 3.2 of the updated CTIS Sponsor Handbook.

Further updates

The latest CTIS release also includes several enhancements and fixes, including:

the ability to upload Proof of Payment for certain substantial modifications following a temporary halt of a clinical trial;
improved functionality allowing sponsors to update the number of trial participants when responding to Requests for Information (RFIs);
corrections to the display of End of Recruitment dates so that draft information is no longer shown before submission; and
additional technical improvements and bug fixes supporting sponsor, Member State and European Commission workflows.

CTIS Information Day materials available

Presentation slides and supporting materials from the latest CTIS Information Day have been published by the European Medicines Agency (EMA). They provide updates on CTIS developments, ongoing system improvements, lessons learned from implementation and future priorities. Find them here.

CTIS Sponsor End User Training – October 2026

Registration is open for the next CTIS Sponsor End User Training Programme, organised virtually by DIA on behalf of EMA in October 2026. The training is designed to support sponsor users in preparing and submitting Clinical Trial Applications (CTAs) through CTIS in accordance with the Clinical Trials Regulation and is suitable for both new and experienced CTIS users. Register here.

New EU templates for recruitment and informed consent

The European Commission has published new EU templates for participant recruitment materials and informed consent documents under the Clinical Trials Regulation. Sponsors should review these templates and consider their use in future clinical trial submissions to support greater consistency and compliance across Member States.

CTIS and Clinical Trials Regulation updates