CTR In Focus: Strategic Planning To Transition To The EU Clinical Trials Regulation

By Xandra Neuberger, Associate Director Regulatory Affairs

As the deadline for the legal transition period for EU clinical trials approaches, companies are facing increasing pressure to smoothly navigate the shift from the old regulatory framework to the Clinical Trials Regulation (CTR) and the Clinical Trial Information System (CTIS). The transition must be completed by January 30, 2025, and strategic planning is essential to avoid any potential legal issues with ongoing trials. Transitioning to the CTR and CTIS requires careful preparation, which involves several critical steps and considerations.

This article outlines the necessary strategies to ensure a smooth transition. From harmonizing core dossiers across member states to establishing an effective administrative setup within CTIS, companies must meticulously orchestrate every aspect of the transition process. Additionally, managing information in databases such as EudraVigilance medicinal product dictionary (XEVMPD) and preparing for potential regulatory delays are vital components that cannot be overlooked.

In this dynamic regulatory landscape, early preparation and comprehensive strategic planning are not just advisable but imperative for companies seeking to sustain their clinical trials in the EU.