After its adoption 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. This regulation seeks to enhance the harmonization of the clinical trial approval process, making the EU a more attractive destination for clinical research.
Sponsors of active clinical trials within the European Union now face additional responsibilities under the new Clinical Trials Regulation. The process for transitioning an active clinical study to comply with the new requirements involves several steps:
- Sponsor Evaluation: Assess the clinical trial's current compliance with the Clinical Trial Regulation and identify the need for transition. Determine if the dossier needs harmonization between Member State Committees and confirm the trial's eligibility for transition.
- Harmonization: Harmonize dossiers via SA application according to CTD.
- Transition: Submit a formal application for transition in the new Clinical Trial Information System (CTIS), requiring a new cover letter and application form module. For multinational trials, the sponsor must declare that part I/part II documents are identical to versions approved by each Member State.
The standard timeline for reviewing the transition application is 60 days, during which the trial cannot be amended. Following the transition, any substantial modification to the trial will require full compliance with the new CTR.
