レギュラトリーサイエンス（RS）のもつ解決志向性とリスク学の親和性―薬事分野・食品安全分野・化学物質管理分野の事例分析からの示唆―

抄録

In this study, we overviewed the historical trends and characteristics of “regulatory science (RS)” and related concepts based on trilateral practical cases (i.e., Japan, the United States, and EU) in three fields (i.e., pharmaceutical affairs, food safety, and chemical management). We then compared RS with trans-science to highlight their practical roles. In the field of pharmaceutical affairs, the concept of RS was applied as science for assessment, regulation, or decision-making under the frame of international harmonization. In the field of food safety and chemical management, terms such as risk analysis were used for the methodologies to support the decision-making toward regulation in advance of RS. Overall, there is a commonality that the concepts of RS and other methodologies in these fields are used for solving decision-making problems, whereas trans-science highlights aspects of problems that science cannot solve. RS has an orientation of solution-focused approach, which is compatible with risk science.