EU Clinical Trial Regulation & Clinical Trial Information System

The European Clinical Trials Regulation (EU CTR) entered into application on 31 January 2022. Under the Regulation, clinical trial sponsors and regulators use the Clinical Trials Information System (CTIS) as single-entry point for submission and assessment of clinical trial data. On 31 January 2023, the use of the CTIS became mandatory for initial applications of clinical trials with at least one site in the EU/EEA. Download our newest report to find out what you need to consider now.

What have we learnt during the first year?

The first year of the transition period to the EU CTR was a valuable learning experience for sponsors who had already submitted trials under the EU CTR. Many clinical trial sponsors have already put in significant effort to adjust their processes in order to be compliant with the EU CTR. However, the end of the first year of transition provides an opportune moment to refine EU CTR processes within organisations due to gained CTIS user experience and system updates.

Transition your trials

With the start of the second year of transition on 31 January 2023, the submission of all new clinical trial application under the EU CTR via CTIS became mandatory. All ongoing trials with at least one active site in the EU/EEA countries on 31 January 2025 will need to be transitioned to the EU CTR. There are many considerations for transitioning clinical trials, some of which industry can foresee and other organisations may come across as they go through a transition. For this reason, it is crucial to ensure there are no delays in transition or that studies must be terminated due to not being transitioned in time.

Optimise your EU CTR readiness

With the first year of transition behind us, stakeholders including EMA, clinical trial sponsors, and Member States have had a chance to prepare for EU CTR and have gained experience with the Regulation and specifically the Clinical Trial Information System. Now is a crucial moment to re-evaluate and refine previously defined EU CTR processes within your organisation. This period provides an opportunity for sponsors to turn their achieved EU CTR readiness into an optimised strategy to fully benefit from the EU CTR.

Three key considerations

In summary, prioritise these three essential considerations to navigate transition:

1. Be proactive and take action now
2. Review the current EU CTR process solutions already implemented by your organisation
3. Consider opportunities for implementing (semi-)automated process elements

Speak to our experts

We have extensive experience in supporting regulators and top pharmaceutical companies to prepare for new Life Science Regulations, and since 2014 we have been helping organisations prepare for the implementation of the Clinical Trials Regulation. We are skilled with differentiating and setting up regulatory frameworks in challenging and diverse jurisdictions. We pride ourselves in supporting organisations in defining and executing optimal strategies for CTR implementation and ensuring they are and remain responsible businesses.