After being adopted by the European Parliament in April 2014, the European Union’s Clinical Trials Regulation (Regulation (EU) No 536/2014) officially took effect on January 31, 2022. The regulation aims to improve the harmonization of the approval process for clinical trials and make the region more attractive as a destination for clinical research.
If you are a sponsor of active clinical trials in the European Union, you may have additional responsibilities under the new Clinical Trials Regulation. But don’t worry. Here are the steps for transitioning an active clinical study in the European Union to the new requirements under the EU Clinical Trial Regulation. For a more in-depth look at the changes, you can read our new white paper A Guide to the EU Clinical Trial Regulation: How to Ensure Timely Transition for Current Studies.
Steps for Transitioning Ongoing Studies
- Sponsor Evaluation
- Evaluate your clinical trial’s current compliance with the Clinical Trial Regulation and identify the need for transition
- Determine whether the dossier needs to be harmonized between Member State Committees
- Confirm if the clinical trial is eligible for transition (no pending/ongoing assessment in any EU or EEA countries)
- Harmonize dossiers via SA application according to CTD
- Make formal application for transition (simplified dossier, no re-assessment!) in the new Clinical Trial Information System
- A new cover letter and new application form module are required to be completed in CTIS (see Figure 1)
- For multinational clinical trials: Sponsor’s declaration that part I/part II documents do not contain significant differences/are identical to the versions approved by each Member State (as applicable)
Figure 1. Documents required to be uploaded in the CTIS for transition
The standard timeline for the review of the transition application is 60 days. During this period, the trial cannot be amended. If and when the trial undergoes the next substantial modification following the date of applicability, the full requirements of the new CTR will apply.
As a privately owned and operated contract research organization headquartered in Switzerland, PSI CRO has continuously monitored and adapted to the changing European regulatory landscape over the last 25 years. Drawing on this experience, we can offer a unique perspective on preparing for this shift in how clinical trials are conducted in the EU. Click here to read our new white paper or get in touch with one of our regulatory affairs experts.