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The European Medicines Agency’s goals for regulatory science to 2025

It is increasingly important that regulatory agencies catalyse the translation of scientific and technological innovation into improved patient-centred health care. Here, we highlight the strategic goals of the European Medicines Agency to advance regulatory science and optimize the opportunities arising in areas such as cell and gene therapies, big data and artificial intelligence.
  1. Philip A. Hines

    1. European Medicines Agency, Amsterdam, Netherlands; The United Nations University–Maastricht Economic and Social Research Institute on Innovation and Technology, Maastricht, Netherlands; Department of International Health, Faculty of Health, Medicine and Life Sciences (FHLM), Maastricht University, Netherlands.

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  2. Richard H. Guy

    1. European Medicines Agency, Amsterdam, Netherlands; University of Bath, Bath, UK; UCSF–Stanford Center of Excellence in Regulatory Science & Innovation, San Francisco, CA, USA.

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  3. Anthony J. Humphreys

    1. European Medicines Agency, Amsterdam, Netherlands.

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  4. Marisa Papaluca-Amati

    1. European Medicines Agency, Amsterdam, Netherlands.

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Transformational advances in cell or gene-based therapies, drug–device combinations, novel clinical trial design, real-world evidence, ‘big data’ and artificial intelligence (AI) present an important challenge to regulatory scientists. Consequently, in 2016, the European Medicines Agency (EMA) formalized a Regulatory Science Observatory to monitor emerging trends in science and technology, and to direct the use of resources and external collaborations to advance regulatory science. The ambition was to identify priority areas where new or enhanced engagement is essential to the continued success of the EMA’s vision — to catalyse and enable science to be translated into patient-centred care and its delivery in evolving health-care systems (see Related links). To fulfil this objective, trends in science, technology and regulatory tools affecting EMA operations were surveyed in-depth and the results were supplemented with outreach activities with stakeholders at all levels of the medicine development pathway (see Supplementary information). The culmination of this effort was a workshop held at the EMA in October 2018, at which five strategic goals were outlined (see Supplementary information and Related links). These goals are highlighted here.

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Nature Reviews Drug Discovery 18, 403-404 (2019)

doi: https://doi.org/10.1038/d41573-019-00071-2

Acknowledgements

The authors thank colleagues and stakeholders for input in shaping the strategy.

Disclaimer

The views expressed in this article are the personal views of the author(s) and may not be understood or quoted as being made on behalf of or reflecting the position of the European Medicines Agency or one of its committees or working parties.

Supplementary Information

  1. Supplementary information

Competing Interests

The authors declare no competing interests.

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