Regulatory science is essential for addressing issues and gaps encountered by stakeholders in medicines research, development and evaluation1,2,3. Research in regulatory science delivers solutions by providing better methodologies for medicines research and development, and improved tools for evaluating medicines based on outcomes that better align with patients’ needs. It drives progress by identifying gaps in the evolving regulatory system and developing new approaches for generating evidence to support decision-making. Tangible impacts of regulatory science research include the revision or creation of new regulatory guidelines, or the qualification of novel methodologies such as biomarkers to support their use in medicines development.

Acknowledgements

We thank colleagues from EMA and the European regulatory network, as well as all the public, who contributed to and helped to shape the development of the Platform. 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 regulatory agencies or organizations with which the authors are affiliated.

The authors declare no competing interests.