EU Clinical Trial Regulation (CTR)
Since 31 January 2022, the EU Clinical Trial Regulation (CTR) is applicable. On this page information is given on what has been changed. Please take note of all the information, follow training and watch webinars.
Information for investigators
All information for investigators is available in a section dedicated to the CTR.
Brochure: The CTR in a nutshell
A brochure published by the Dutch Clinical Research Foundation (DCRF) describes the changes in a nutshell.
From 31 January 2022 on a transition period of three years is applicable. During the first year, sponsors may choose to submit a clinical trial application according to the current legislation, or according to the CTR via CTIS.
Clinical Trials Information System (CTIS)
The Clinical Trials Information System (CTIS) contains the centralised EU portal and database for clinical trials foreseen by the CTR. CTIS is the single entry point for submitting the clinical trial application in the EU. The system supports the day-to-day business processes of Member States and sponsors throughout the life-cycle of a clinical trial. The European Medicines Agency (EMA) has set up and will maintain CTIS, in collaboration with the Member States and the European Commission.
CTIS sponsor handbook
EMA provides a handbook on CTIS for sponsors of clinical trials.
CTIS training programme
A training programme on CTIS is also available on EMA’s website.
CTIS information events
EMA organises information events on CTIS.
EMA regularly publishes 'CTIS highlights' with news on the development of CTIS:
Would you like to subscribe to CTIS highlights? Please send an e-mail to firstname.lastname@example.org.
Q&A document: Answers to frequently asked questions
A Q&A document from the European Commission provides answers to frequently asked questions about the CTR.