The Accelerating Clinical Trials in the EU (ACT EU) initiative has taken a significant step forward with the launch of two new advice pilots aimed at enhancing the quality of clinical trial applications. These pilots are pivotal for advancing the development of safe and effective medicines across Europe.
ACT EU is a joint effort by the European Medicines Agency (EMA), the Heads of Medicines Agencies (HMA) from Member States, and the European Commission (EC). This initiative is dedicated to transforming the initiation, design, and execution of clinical trials in Europe.
Pilot 1: Joint Scientific Advice for Clinical Trials and Marketing Authorisation Applications
The first pilot focuses on providing developers of medicinal products with scientific advice on clinical trials and marketing authorisation applications (MAA). Traditionally, assessors of clinical trials and those involved in scientific advice for MAAs have operated separately. This pilot brings together the Scientific Advice Working Party (SAWP) and the Clinical Trials Coordination Group (CTCG) for the first time to offer joint scientific advice.
SAWP: Coordinated by EMA, responsible for advice on marketing authorisation applications.
CTCG: Managed by HMA, oversees clinical trial applications.
By consolidating the views of these two groups, the pilot aims to minimize divergences and enhance the consistency of scientific advice.
Pilot 2: Pre-Submission Support for Clinical Trial Applications
The second pilot, coordinated by the CTCG, offers technical and regulatory support for clinical trial applications (CTA) before their submission through the Clinical Trials Information System. Previously, such support was only available at the national level from the Member State evaluating the application. This pre-CTA pilot provides a consolidated perspective from multiple Member States on various pre-submission topics, including regulatory aspects of low interventional clinical trials and trials with decentralised or complex designs.
How to Participate
Starting today, medicinal product developers can apply for advice through these pilots. The effectiveness and duration of the pilots will be assessed based on feedback and data collected from participants. The outcomes will guide the ACT EU steering group in optimizing clinical trial support in the future.
Strengthening European Coordination
By enhancing the coordination within the European medicines regulatory network, these pilots aim to provide applicants with robust support, improving the quality of applications for both marketing and clinical trial authorisations.
Launched in January 2022, ACT EU aims to establish the EU as a leader in clinical research, promoting the development of high-quality, safe, and effective medicines. The initiative’s multi-annual work plan for 2023-2026 outlines several priority action areas to achieve these goals.
These two new advice pilots represent a significant advancement in the way clinical trials are conducted in Europe. By offering comprehensive support and fostering collaboration among key regulatory bodies, ACT EU is set to revolutionize clinical research and the development of medicines across the continent.
