Connect with us


The EU Reinvents Itself to Lead the Development of Clinical Trials

The European Union plans to become an important point for clinical trials. The work plan is structured according to the ten ACT EU priority actions and has been prepared based on the recommendations of the European Medicines Agency Network Strategy 2025 and the European Commission’s Pharmaceutical Strategy for Europe.



The European Commission (EC) and the European Medicines Agency (EMA) have published the 2022-2026 roadmap of the Accelerating Clinical Trials in the EU (ACT EU) initiative that aims to transform the way clinical trials are initiated, designed, and executed in the European Union.

The horizon of this initiative aims to make the EU “a focal point for clinical research, promote the development of high quality, safe and effective medicines, and improve the integration of clinical research into the European healthcare system.”

ACT EU explains the EMA, will strengthen the European environment for clinical trials while maintaining the high level of protection for trial participants, the robustness of data, and transparency expected by EU citizens.

The ACT EU multi-year work plan builds on the Clinical Trials Regulation (CTR), which entered into force in January 2022, and the activities of the European regulatory network to support clinical trials. The work plan highlights key focus areas, such as innovation in clinical trials, robust methodologies, and collaboration between stakeholders.

The work plan is structured according to the ten ACT EU priority actions and has been prepared based on the recommendations of the European Medicines Agency Network Strategy 2025 and the European Commission’s Pharmaceutical Strategy for Europe.

Read more on the subject and find the latest business news from around the world with our companion app Born2Invest.

The work plan sets out deliverables and timelines for clinical trials

The following are planned for 2023: Large multinational clinical trials: the establishment of a support process specifically targeting academic sponsors in order to make the EU a more attractive region to conduct clinical research. CTR implementation: a particular focus on the Clinical Trials Information System (CTIS) and CTR training activities and the resolution of any issues encountered by clinical trial sponsors.

Multi-stakeholder platform: to be established in 2023 to facilitate the evolution of the clinical trial environment through regular dialogue between all stakeholders, including patients, healthcare professionals and academics, to find practical solutions to enable and drive change. Modernization of good clinical practice: ACT EU will support not only the adoption but also the implementation of the revised EU guidelines on clinical trial technology and design.

And finally, facilitation of innovative clinical trial methods: the initiative will issue guidance on decentralized clinical trials by the end of 2022 and publish a methodological roadmap to identify and prioritize key advances in clinical trial methods.


(Featured image by dimitrisvetsikas1969 via Pixabay)

DISCLAIMER: This article was written by a third party contributor and does not reflect the opinion of Born2Invest, its management, staff or its associates. Please review our disclaimer for more information.

This article may include forward-looking statements. These forward-looking statements generally are identified by the words “believe,” “project,” “estimate,” “become,” “plan,” “will,” and similar expressions. These forward-looking statements involve known and unknown risks as well as uncertainties, including those discussed in the following cautionary statements and elsewhere in this article and on this site. Although the Company may believe that its expectations are based on reasonable assumptions, the actual results that the Company may achieve may differ materially from any forward-looking statements, which reflect the opinions of the management of the Company only as of the date hereof. Additionally, please make sure to read these important disclosures.

First published in diariofarma, a third-party contributor translated and adapted the articles from the originals. In case of discrepancy, the original will prevail.

Although we made reasonable efforts to provide accurate translations, some parts may be incorrect. Born2Invest assumes no responsibility for errors, omissions or ambiguities in the translations provided on this website. Any person or entity relying on translated content does so at their own risk. Born2Invest is not responsible for losses caused by such reliance on the accuracy or reliability of translated information. If you wish to report an error or inaccuracy in the translation, we encourage you to contact us.

Anthony Donaghue writes about science and technology. Keeping abreast of the latest tech developments in various sectors, he has a keen interest on startups, especially inside and outside of Silicon Valley. From time to time, he also covers agritech and biotech, as well as consumer electronics, IT, AI, and fintech, among others. He has also written about IPOs, cannabis, and investing.