Regulatory Science to 2025: An Analysis of Stakeholder Responses to the European Medicines Agency's Strategy

Philip A. Hines*, Rosa Gonzalez-Quevedo, Apolline I. O. M. Lambert, Rosanne Janssens, Barbara Freischem, Jordi Torren Edo, Ivo J. T. M. Claassen, Anthony J. Humphreys

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review


The pace of innovation is accelerating, and so medicines regulators need to actively innovate regulatory science to protect human and animal health. This requires consideration and consultation across all stakeholder groups. To this end, the European Medicines Agency worked with stakeholders to draft itsRegulatory Science Strategy to 2025and launched it for public consultation. The responses to this consultation were analyzed qualitatively, using framework analysis and quantitatively, to derive stakeholders' aggregate scores for the proposed recommendations. This paper provides a comprehensive resource of stakeholder positions on key regulatory science topics of the coming 5 years. These stakeholder positions have implications for the development and regulatory approval of both human and veterinary medicines.
Original languageEnglish
Article number508
Number of pages21
JournalFrontiers in medicine
Publication statusPublished - 23 Sept 2020


  • regulatory science
  • regulation
  • innovation
  • stakeholder engagement
  • patient access
  • benefit-risk assessment

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