Considerations For Compliance With CTIS Submissions Under The EU-CTR

By Michael Halaiko and Alexandra Moylan

Effective Jan. 31, 2023, all new applications for clinical trials within the European Economic Area (EEA) must be submitted through a central web-based portal called the Clinical Trial Information System (CTIS), in accordance with the EU’s Clinical Trial Regulation (EU-CTR) under Regulation No. 536/20141. CTIS was developed and implemented to serve the dual purpose of 1) simplifying the clinical trial application process and submission of clinical trial data and results within the EEA (which consists of EU member states, plus Iceland, Norway, and Liechtenstein), and 2) furthering the EUCTR’s goal of public transparency and data availability regarding clinical trials.