In June 2024 the European Medicines Agency (EMA) announced that the Accelerating Clinical Trials in the EU (ACT EU) initiative is launching two advice pilots to improve the quality of applications for clinical trials in Europe. Launched in January 2020, ACT EU aims to “further develop” the EU as a “focal point for clinical research”, promote the development of high-quality, safe, and effective medicines, and better integrate clinical research into the European health system. It is a collaboration between the EMA, the Heads of Medicines Agencies (HMA) in the Member States, and the European Commission (EC).
The pilots will be evaluated over time based on data and feedback from applicants. The information will inform a possible change of scope and final decision from the ACT EU steering group on how to optimise clinical trial support in the future.
“By strengthening the coordination of the European medicines regulatory network, these advice pilots offer applicants additional support to enhance the quality of their applications for marketing and/or clinical trial authorisation.”
The first pilot
The first pilot offers developers of medicinal products scientific advice on clinical trials and requirements for marketing authorisation applications. EMA suggests that clinical trials assessors are “not consistently involved” in scientific advice procedures for marketing authorisation applications, and vice versa. Through this programme, the Scientific Advice Working Party (SAWP), coordinated by EMA, and the Clinical Trials Coordination Group (CTCG), managed by HMA, will assess incoming requests of a scientific nature. The SAWP is responsible for advice on marketing authorisation applications and the Member States represented at CTCG oversee clinical trial applications (CTA). The pilot consolidates the views of both groups to “minimise avoidable divergences”.
The second pilot
The second pilot is coordinated by the CTCG and provides technical and regulatory support on the dossier of a CTA before it is submitted through the Clinical Trials Information System. Before the pilot, applicants could only get technical and regulatory support at national level from the Member State that is evaluating the application. The pre-CTA pilot is to provide consolidated views of the Member States concerned on pre-submission topics. The pilot covers areas such as advice on regulatory aspects of low interventional clinical trial status and submission of trials with decentralised elements or complex designs.
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