09/22/2025
Photo by Christian Lue on Unsplash
On January 31st, 2025, the European Medicines Agency (EMA) reached another major milestone for the implementation of the Clinical Trials Regulation (CTR) (Regulation (EU) No 536/2014), the European Union’s (EU) current pharmaceutical legislation. Prior to the CTR, the regulatory framework for clinical trials in the EU was the Clinical Trials Directive 2001/20/EC (CTD) which, once it came into full effect in 2004, regulated how clinical trials were authorized, conducted and reported in accordance with Good Clinical Practice (GCP) standards. The CTR has updated the many of the CTD policies; promoting communication between trials and regulators, increased transparency between trials and the public, and reducing financial and administrative burdens.
The new regulations were initially adopted in 2014; however, there were significant delays in its implementation due to issues with development of the cornerstone Clinical Trials Information System (CTIS). The CTIS is an online portal between study sponsors and regulatory authorities of EU Member States where sponsors can submit applications, receive approval and communicate with authorities throughout the trial’s lifecycle. Similar to ClinialTrials.gov, the public is able to view information about the trial including the therapeutic area, details on the sponsor, and start/end dates for participant recruitment which promotes transparency within studies. On January 31st, 2022, the CTR and CTIS were officially launched, repealing the CTD. At this time those conducting clinical trials were informed of the relevant transition periods to change policies and trial conduct to comply with the new regulations. Within the first year of the transition (Jan 2022- Jan 2023) sponsors could choose between submitting trial applications under the CTD through the EudraCT system or the CTR’s CTIS. Starting the second year, January 31st 2023, initial applications had to be submitted under the CTR while existing trials could remain under the CTD. Following the end of the third transitional year (January 31st, 2025), all trials are now regulated by the CTR and any trial found not in compliance with the CTR may be subject to corrective measures.
With the CTR and CTIS now in full effect, the EU can remain competitive with other popular clinical trial destinations such as the US when sponsors are considering where to conduct their trials. To further support the CTR and development of research, the Accelerating Clinical Trials in the EU (ACT EU) initiative was also launched in January of 2022. ACT EU looks to find innovative ways to improve the transparency and efficiency of how clinical trials are designed, conducted, and reported. By establishing the Multi-Stakeholder Platform, a collaborative advisory group that consists of trial patients, sponsors, regulators and other relevant parties, ACT EU addresses first-hand concerns and issues within the clinical ecosystem to help provide meaningful change to the industry. In December of 2024, the ACT EU released their 2025-2026 workplan which highlights the initiative’s current progress and outlines their goals for the future including key dates for workshops and meeting (For more information about ACT EU see our previous post).
With all of these changes from the CTD to the CTR, it is important to understand what is expected of sponsors and other stakeholders in the region from a regulatory perspective. As is the case with FDA regulated trials, EU trials are also subject to inspections and whether or not a trial passes these inspections determines if the investigational product will proceed to market. Clinical Pathways offers specialized online training in regulatory requirements for clinical trials in the EU that covers everything from new rules and regulations within the CTR to use of the new CTIS. Visit our online store to see if any of our other online courses could benefit you or your company and while you are there make sure to sign up for our free blog and newsletter to stay up to date on clinical trial related news such as this.
-The Clinical Pathways Team
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