As the most significant change in the European Union clinical trial legislative ecosystem in 20 years, the European Union Clinical Trial Regulation 536/2014 (EU CTR) went live on January 31, 2022. The first-year transition period has now ended, and from January 31, 2023, EU Clinical Trial Regulation became compulsory for all new interventional clinical trials of investigational medicinal products. All ongoing trials approved under the previous regulatory framework (EU Clinical Trial Directive 2001/20/EC) in the scope of the EU CTR will have to end or transition to comply with the new regulation by January 31, 2025. In that context, sponsors and clinical trial applicants need both internal readiness of their organization as well as expansion of EU CTR for new and ongoing studies (at least for those not ended by early 2025) in order to prepare for its multiple operational impacts. For optimal EU CTR readiness, the following points must be considered:

• Assessing EU CTR’s impact on the organization and planning readiness strategies based on the development portfolio (ongoing and planned)
• Managing submission activities using the new EU Portal, Clinical Trial Information System (CTIS), while accounting for evolving transparency rules
• Optimizing translation management for expedited handling of ethics/regulatory queries (up to 12 calendar days turnaround time)
• Piloting studies under EU CTR to confirm/adjust implementation strategies as needed
• Developing/evolving transparency strategies regarding the disclosure principles applied with EU CTR including authoring, redacting and deferring setup for study documents submitted or to be generated at the end of the trial
• Updating standard operating procedures (SOPs) and work instructions for those matters affected globally by this regional regulation, including the impact on external vendors contracted for clinical-trial-related activities
• Training teams to evolve their operational practices (clinical, medical, regulatory, transparency, etc.) to the new EU regulatory framework