IMP Labeling: EU CTR Transition Considerations

The EU Clinical Trial Regulation (EU CTR) became effective on January 31, 2022, with the first-year transition period ending on January 30, 2023. As a result, the use of the Clinical Trial Information System (CTIS) is now compulsory for all initial submissions of interventional clinical trials involving one or more European Union (EU)/European Economic Area (EEA) member states (MS).

For trials that were approved under the EU Clinical Trial Directive (EU CTD) and are still ongoing by January 30, 2025, a formal transition to the EU CTR (national decision in place) will be required by that date. However, until then, studies can continue operating under the EU CTD regulations. This raises questions about managing ongoing trials authorized under the EU CTD and the potential impact of EU CTR implementation on investigational medicinal product (IMP) labeling strategy and planning.

Considering the second transition period from 2023 to 2025, it is important to understand the implications it has on IMP labeling activities. Review the current requirements, supporting guidance, and three key considerations when planning IMP labeling activities for ongoing studies by accessing the full article below.