01/30/2023
Image by Gerd Altmann from Pixabay
Beginning January 31, 2023, the Clinical Trials Information System (CTIS) is required for all new clinical trial applications that are applicable to the European Medicines Agency (EMA). The Clinical Trials Regulation (CTR) (Regulation (EU) No 536/2014) entered into application January 31, 2022, which also launched the CTIS with a one year transition period. During the transition time, new clinical trial applications could follow either the repealed Clinical Trials Directive (2001/20/EC) or the Clinical Trials Regulation through CTIS. Under the Directive, applications were sent separately to ethics committees and regulatory agencies for each country. CTIS streamlines the process with only one application needed for approximately 30 countries in the European Union. Applications are also more easily reviewed and approved using the CTIS. Any ongoing clinical trials that were approved under the Directive need to transition to CTIS by January 31, 2025.
You may also be interested in our blog on the EU Clinical Trials Initiative Strategy Paper – ACT EU
- The Clinical Pathways Team
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