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Accelerating clinical trials in the EU (ACT EU): transforming the EU clinical trials landscape

Accelerating Clinical Trials in the EU (ACT EU) is an initiative developed by the European Commission, Heads of Medicines Agencies and the European Medicines Agency to transform the clinical trials landscape in the European Union. It aims to foster regulatory, technological and process innovation to support better, faster and optimized clinical trials.
By
  1. Giacomo Capone

    1. European Medicines Agency, Amsterdam, the Netherlands.

  2. Björn Eriksson

    1. Läkemedelsverket, Uppsala, Sweden.

  3. Monique Al

    1. Central Committee on Research Involving Human Subjects, The Hague, the Netherlands.

  4. Stan van Belkum

    1. Central Committee on Research Involving Human Subjects, The Hague, the Netherlands.

  5. Karl Broich

    1. Bundesinstitut für Arzneimittel und Medizinprodukte, Bonn, Germany.

  6. Maria Lamas

    1. Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain.

  7. Marianne Lunzer

    1. AGES MEA, Vienna, Austria.

  8. Lorraine Nolan

    1. Health Products Regulatory Authority, Dublin, Ireland.

  9. Catriona Ester

    1. European Medicines Agency, Amsterdam, the Netherlands.

  10. Juan Garcia Burgos

    1. European Medicines Agency, Amsterdam, the Netherlands.

  11. Laura Pioppo

    1. European Medicines Agency, Amsterdam, the Netherlands.

  12. Ana Zanoletty

    1. European Medicines Agency, Amsterdam, the Netherlands.

  13. Peter Arlett

    1. European Medicines Agency, Amsterdam, the Netherlands.

Introduction

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Nature Reviews Drug Discovery 23, 797-798 (2024)

doi: https://doi.org/10.1038/d41573-024-00085-5

Acknowledgements

We thank the European Commission for their co-leadership of the ACT EU initiative. We also thank the ACT EU priority action coordinators and Valentina Di Biase and Jarno Jansen for their review of the manuscript.

Disclaimer

The views expressed in this article are the personal views of the authors and may not be understood or quoted as being made on behalf of, or reflecting the position of the European Commission or its services, the European Medicines Agency or one of its committees or working parties, or the regulatory agency or organizations with which the author(s) is/are employed/affiliated.

References

  1. Cavaleri, M., Sweeney, F., Gonzalez-Quevedo, R. & Carr, M. Shaping EU medicines regulation in the post COVID-19 era. Lancet Reg. Health Eur. 9, 100192 (2021).

    Article  PubMed  Google Scholar 

  2. ACT EU multi-annual Workplan 2022–2026 (Accelerating Clinical Trials in the EU, 2022); https://accelerating-clinical-trials.europa.eu/system/files/2023-04/act-eu-multi-annual-workplan-2022-2026_en.pdf

  3. Accelerating Clinical Trials in the European Union (ACT EU). Concept paper: an EU multi-stakeholder platform for improving the EU clinical trials environment (Accelerating Clinical Trials in the EU, 2023); https://accelerating-clinical-trials.europa.eu/system/files/2023-10/ACT%20EU%20multi-stakeholder%20platform%20concept%20paper%20final%20update_1.pdf

  4. COVID-19 Lessons learned. Joint report on the response to the Public Health Emergency (European Medicines Agency, 2023); https://www.ema.europa.eu/en/documents/report/covid-19-lessons-learned-joint-report-response-public-health-emergency_en.pdf

  5. Report of the EMA/ETF workshop on Lessons Learned on Clinical Trials in Public Health Emergencies (European Medicines Agency, 2023); https://www.ema.europa.eu/en/documents/report/report-emaetf-workshop-lessons-learned-clinical-trials-public-health-emergencies_en.pdf

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Competing Interests

The authors declare no competing interests.

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