Assessing Readiness For EU Clinical Trials Regulation (CTR): Five Points To Consider

The EU Clinical Trials Regulation (EU CTR) came into effect on January 31, 2022. Following a one-year transition period, starting from January 31, 2023, the EU CTR is now mandatory for all initial submissions of interventional clinical trials involving investigational medicinal products conducted in one or more EU/European Economic Area (EEA) Member States. Ongoing trials that were authorized under the previous EU Clinical Trial Directive (EU CTD) can continue under that framework for the time being. However, if these trials are still in progress by January 30, 2025, they will be required to transition to the EU CTR.

To ensure compliance with the EU CTR, sponsors and clinical trial applicants should carefully consider its impact on their organization's infrastructure. This includes aspects such as quality management systems, outsourcing strategy, vendor management, regulatory intelligence gathering, and training. Additionally, they need to assess the implications for study management and operational conduct activities, encompassing regulatory compliance, clinical operations, transparency requirements, and other relevant areas.

To evaluate readiness for the EU CTR, access the five key points below to better analyze an organization's readiness and make any necessary adjustments to meet compliance.