EU Clinical Trial Regulation: Impact and strategic considerations for sponsors

The European Union Clinical Trial Regulation 536/2014 (EU CTR) introduces fundamental changes for interventional clinical trial submissions and approvals in all 30 countries of the European Union and the European Economic Area.

The EU CTR has established a harmonised approach for clinical trial applications, assessment and reporting with consistent rules. The ultimate aim is to ensure the highest safety standards for clinical trial participants by strengthening transparency and consistency. A key feature of the EU CTR is the introduction of a single electronic portal, the Clinical Trial Information System (CTIS), which is mandatory for all EU CTR submissions.

Following its implementation in January 2022 there has been a phased transition period for new and ongoing clinical trials. As of 31st January 2023, all new European Union or European Economic Area Member State submissions must be made via the EU CTR process.

In this white paper, ICON’s experts offer strategic considerations for sponsors in addition to providing insights on the following:

• CTIS, including interaction with other systems and databases
• Clinical trial submission process
• Transition of existing Clinical Trial Applications
• Timelines and requests for information (RFI)
• ICON’s experience with the EU CTR