Insights
Updates for Sponsors on the transition of clinical trials into the CTIS system
The three-year transition period established by Article 98 of Regulation (EU) No. 536/2014 is coming to an end, with critical implications for ongoing clinical trials conducted under Directive 2001/20/EC.
As per the AIFA Determination effective by 31 January 2025, any clinical trials not transitioned to the CTIS by 30 January 2025 will face:
- Revocation: Authorizations for trials that fail to submit a transition application will be revoked.
- Suspension: Trials with submitted but incomplete transition applications will be suspended until the transition is finalized and approved via the CTIS portal.
Revoked or suspended trials must immediately halt all study activities, including final patient visits and protocol-specific interventions. Sponsors are responsible for promptly notifying all involved parties and ensuring the safety and well-being of trial participants during this period, in accordance with legal obligations.
This milestone emphasizes the need for compliance with Regulation (EU) No. 536/2014 to maintain continuity in clinical research. All Sponsors are urged to complete their transition applications without delay.
RPN will provide further updates on this hot topic and will support to ensure a seamless transition to the CTIS system, offering regulatory assistance for all clinical trial needs.