EMA: Clinical Trials Information System (CTIS): Readiness for mandatory use of the Clinical Trials Regulation from 31 January 2023

The European Medicines Agency is offering this open event to provide:

reflection on the implementation of the Clinical Trials Regulation

update on the current status of CTIS

outlook on 2023/2024 CTIS planning

The Clinical Trials Information System (CTIS) was launched on 31 January 2022, starting the clock for one-year transition period for all sponsors of clinical trials.

During the transition period, clinical trial sponsors can choose whether to submit an initial clinical trial application in line with the Clinical Trials Directive or under the Clinical Trials Regulation (CTR), via CTIS.

Starting from 31 January 2023, the use of CTIS will be mandatory for all initial clinical trial application in the European Union (EU).

EMA cannot provide attendees certificates of attendance for this event.

A video recording is made available after the event. Processing and publication of the video recording typically take up to 60 days. Please subscribe to the Clinical Trials Highlights newsletter for updates on the availability of CTIS event video recordings.

Fri, 20.1.2023 | 10:00 - 13:00


EMA website with additional information on this event