The Accelerating Clinical Trials in the EU (ACT EU) initiative is today launching two advice pilots aimed at improving the quality of applications for clinical trials, the foundation for the development of safe and effective medicines in Europe.

ACT EU is a collaboration between the European Medicines Agency (EMA), the Heads of Medicines Agencies (HMA) in the Member States and the European Commission (EC), which seeks to transform how clinical trials are initiated, designed, and run.

The first pilot offers developers of medicinal products scientific advice on clinical trials and on requirements for marketing authorisation applications (MAA). Assessors of clinical trials are not consistently involved in scientific advice procedures for MAAs, and vice versa. In this pilot programme, the Scientific Advice Working Party (SAWP), coordinated by EMA, and the Clinical Trials Coordination Group (CTCG), managed by HMA, will be the bodies assessing 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). This pilot consolidates the views of these two groups to minimise avoidable divergences. It is the first time that both entities are providing joint scientific advice on clinical trials.

The second pilot is coordinated by the CTCG and provides technical and regulatory support on the dossier of a CTA prior to its submission through the Clinical Trials Information System. Before this pilot, applicants could only receive technical and regulatory support at national level from the Member State evaluating the application. The pre-CTA pilot will provide consolidated views of the Member States concerned on pre-submission topics. The scope of this pilot covers a number of areas such as advice on regulatory aspects of low interventional clinical trial status and submission of trials with decentralised elements or complex designs, to name a few.

Starting today, developers of medicinal products who wish to receive advice on the requirements for a MAA or a CTA may apply to these pilots. The duration of both pilots will be evaluated over time based on data and feedback collected from applicants. All this information will inform a possible change of scope and a 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.

Background

ACT EU was launched in January 2022 and aims to further develop the EU as a focal point for clinical research, to promote the development of high-quality, safe and effective medicines, and to better integrate clinical research in the European health system. ACT EU features priority action areas that are the basis for the ACT EU multi-annual workplan 2023-2026.

 

Notes

  1. Guidance to apply to the advice pilots is available via external documents below.

  2. Information sessions on the two pilots will be organised shortly and announced at the EMA website.

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