January 2022: Accelerating Clinical Trials in the EU (ACT EU) Update

European Medicines Agency updated about a new initiative, “Accelerating Clinical Trials in the EU (ACT EU): for better clinical trials that address patients’ needs “ launched and co-led by EMA, Head of Medicines Agency (HMA), and European Union (EU) over the What’s New Section on January 13, 2021:

The main purpose behind this initiative is the transformation in initiating, designing, and running a clinical trial. Following the launch of CTIS on 31 January 2022, ACT EU is aimed to strengthen the European environment for clinical trials along with maintaining the high level of protection of trial participants, data robustness, and transparency. EMA also published a paper, “Accelerating clinical trials in the EU (ACT EU) – Delivering an EU clinical trials transformation initiative,” that provides information on high-level regulatory network objectives, governance, organization, resourcing, and top ten priority actions for 2022-2023. The key priorities concerning disclosure include:

  • To successfully and promptly implement the CTR and its acts
  • To reinforce the coordination between scientific advice on CT approval and design and a link between the methodologies working party domain.
  • To deliver a clinical trials training curriculum including modules on drug development and regulatory science with links to universities and SMEs (serving as an educational ‘ecosystem’).

The implementation of ACT EU is planned to play a key role in delivering the Network strategy to 2025 and the Commission Pharmaceutical Strategy. Further information will be provided on EMA and HMA web pages.

For more information, please click here.