Regulatory Science: exploring an emerging scientific discipline in health care.

Regulatory Science has gained increasing prominence in the regulatory community, yet its character as a scientific discipline remains insufficiently clarified. While the term is widely used to describe activities that support regulatory decision-making, a unified normative anchoring is lacking. Existing definitions vary considerably in scope, often reflecting specific institutional contexts rather than a coherent scientific framework. This perspective examines Regulatory Science by reflecting on its scientific characteristics, intention, and potential contribution to effective regulation in the European health system. The article explores Regulatory Science as an emerging discipline by applying a humanity-based approach of conceptually scrutinizing its scientific core. By integrating insights from existing, non-congruent definitions, current activities, and regulatory practice, this perspective argues that Regulatory Science extends beyond compliance-oriented regulatory activities and product-specific assessment. Instead, it is positioned as a scientific approach to systematic, evidence-based reflection on regulatory systems, their functioning, and their further development in response to real market needs. Regulatory Science is proposed to provide the methodological foundation for meaningful regulation, consistent with its recitals that provide the objective for regulatory requirements. Based on this reflection, the article postulates conditions under which Regulatory Science can be justified as a distinct scientific discipline. It contributes to its further constitution in the scientific field through highlighting a required normative structure. This results in the proposal of a new, refined definition emphasizing regulation itself as the research objective, the need for scientific methodology, and its overall intention.