Regulatory Factsheet
The Clinical Trials Regulation and the Clinical Trials Information System
The way clinical trials (CTs) are conducted in the European Union (EU) will undergo a major change when the Clinical Trials Regulation (CTR) (Regulation (EU) No 536/2014) comes into application on 31 January 2022. The CTR replaces and expands the scope of the existing EU CT Directive (CTD) 2001/20/EC. The CTR will also apply to all CTs previously authorised under the CTD if still ongoing after 31 January 2025 (see also transition period). The CTR does not apply to non-interventional studies.
