EU Clinical Trial Regulation (CTR)

On 31 January 2022, the EU Clinical Trial Regulation (CTR) will be applicable. On this page information is given on how to get ready for this change. 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.

Transition period

A transition period of three years will apply once the CTR has come into force. 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) will contain the centralised EU portal and database for clinical trials foreseen by the CTR. CTIS will be the single entry point for submitting the clinical trial application in the EU. The system will support the day-to-day business processes of Member States and sponsors throughout the life-cycle of a clinical trial. The European Medicines Agency (EMA) sets up and maintains 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.

CTIS highlights

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 ct.communication@ema.europa.eu.

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.