Accelerating Clinical Trials in the EU (ACT EU)

On 13 January 2022 the EMA launched an EU clinical trials transformation initiative.

On 13 January 2022, the European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) launched an initiative to transform how clinical trials are initiated, designed and run, referred to as Accelerating Clinical Trials in the EU (ACT EU). The aim is to further develop the EU as a focal point for clinical research, further promote the development of high quality, safe and effective medicines, and to better integrate clinical research in the European health system.

This paper sets out proposals for the initial set up of an EU clinical trials transformation initiative: Accelerating Clinical Trials in the EU (ACT EU). The paper includes high-level regulatory network objectives, governance, organization, priority actions for 2022-2023, and resourcing. The implementation of ACT EU will contribute to delivering the Network strategy to 2025 and the Commission Pharmaceutical Strategy.

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