Institute of Good Manufacturing Practices India®

European Medicines Agency necessitates Clinical Trials Information System in 2023

Starting 31 January 2023, the new Clinical Trials Information System (CTIS) will become mandatory as per EMA. CTIS functions as a single entry point of contact for the submission and review of clinical trial data in all EU and EEA countries. 

The CTIS aims to immensely facilitate the daily business of sponsors in the EU. Earlier, the sponsors had to submit clinical trial applications individually to competent national authorities (NCAs) and ethics committees (ECs) in each European country to acquire regulatory clearance. Publication of the trial data is also built into the system.


Up until 30 January 2023, the clinical trial sponsors can opt to submit an initial clinical trial application in line with the Clinical Trials Directive (EC) No. 2001/20/EC or through CTIS.

However, 31 January 2023 onwards, submission of initial clinical trial applications through CTIS becomes compulsory.

By 31 January 2025, all ongoing trials authorised under the Clinical Trials Directive No. 2001/20/EC will be overseen by the new Regulation and must be transitioned to CTIS.

Matching the timeline, the EMA issued a revised version 6.2 of the Q&A on the new clinical trial regulation along with the descriptive material and YouTube videos on the subject.