Use of Clinical Trials Information System becomes mandatory for new clinical trial applications in the EU

News Category: Regulatory news

Date: 31/01/2023

From today, 31 January 2023, all initial clinical trial applications in the European Union (EU) must be submitted via the Clinical Trials Information System (CTIS). CTIS is now the single-entry point for sponsors and regulators of clinical trials for the submission and assessment of clinical trial data. This follows a one-year transition, during which sponsors could choose whether to apply for a new clinical trial in the EU/EEA in line with the Clinical Trials Directive or under the new Clinical Trials Regulation (CTR), which entered into application on 31 January 2022.

Further details can be found on the EMA website. 

For additional information see also:

• the EU dedicated website which supports the undertaking and oversight of clinical trials in the EU and the EEA;
• the EMA's CTIS training and support page;
• our dedicated website section on Clinical Trials Regulation.