Specific rules for the submission, assessment and conduct of clinical trials with medicinal products are set out in the EU Clinical Trial Regulation 536/2014 (CTR). The CTR applies in the European Union as of 31 January 2022.

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.

Since the launch of CTIS, sponsors can apply for clinical trial approval either through the CTR via CTIS, or according to the current legislation (Clinical Trials Directive, CTD).

From January 31, 2023, all new clinical trials application will be submitted through CTIS.

More information can be found on the CCMO website in a section dedicated to the CTR, a CTR Q&A about the situation in the Netherlands, the EMA newsletter Clinical Trials Highlights and in the updated CTR Q&A of the European Commission.

For our local procedures see the website of Clinical Monitoring Center (CMC). If you have any questions about the submitting procedure within the framework of the CTR, please contact the CMC via ctis@amsterdamumc.nl.