Navigating new EU regulations in the clinical supply chain
Navigating new EU regulations in the clinical supply chain
Understanding the EU Clinical Trial Regulation (CTR) is crucial for clinical trial sponsors as it marks a significant shift in how trials are authorised and managed across Europe.
The CTR was introduced in the EU in January 2022 to improve efficiency in new trial regulatory processes. Sponsors can now apply for clinical trial authorisation in up to 30 European countries from a single application, eliminating the need for separate authorisations from national authorities and ethics committees.
Alongside the CTR, the EU has introduced a new unified portal for submitting and managing trial data, the Clinical Trials Information System (CTIS) regulatory platform.
The platform was launched to reduce the need for duplicate work and improve consistency in application assessments. All clinical trials in the EU from 30 January 2025 must now comply with CTR and be submitted through the CTIS. This includes CROs operating in the EU.
However, the introduction of the CTIS has not been without its challenges. Full implementation has been slow due to delays with adoption and hesitancy, technical limitations, manual data entry, and organisational restructuring for some sponsors.
In this latest insight, we explore how the EU’s new Clinical Trial Regulation (CTR) and the CTIS platform are reshaping clinical trial approvals and supply chain operations, offering streamlined processes and transparency, while introducing new challenges in logistics, compliance, and supply planning.