The Clinical Trial Regulation (CTR; EU No. 536/2014) and the Clinical Trial Information System (CTIS) came into application on January 31, 2022 in the European Union and European Economic Area. The CTR repealed the EU Clinical Trials Directive (EC) No. 2001/20/EC and national legislation that was put in place to implement the Directive. The CTR is adopted to overcome the identified gaps and to ensure a higher level of harmonisation regarding the authorisation of clinical trials in the EU.
The assessment and supervision processes for clinical trials throughout the EU are foreseen by the EU CTR via a centralised portal ‘CTIS.’ After the go live on January 31, 2022, clinical trial sponsors can register their trial in the CTIS, rather than in the European Union Drug Regulating Authorities Clinical Trials Database (EudraCT), although they may continue to use the EudraCT for a transition period. The CTIS will centralise the submission, assessing, authoring, and supervision processes for clinical trial application (CTA).