Interaction analysis between innovation and regulation: The concept of Regulatory Science as a Process (RaaP) and its applications

The jurisdiction against emerging technologies is a core process for designing “Technology Management for Social Innovation.” The concept of “Regulatory Science” (RS) in technology jurisdiction has a diverse range of meanings among its users in the medical field. Thus, the analysis of interactions between innovation and regulation is not generalized and includes systematic approaches. RS is categorized as “a third-party science,” differing from a basic science or an applied science, and is recognized as constituting “adaptive activities” against innovator's activities. This study proposes the concept of “Regulatory Science as a Process” (RaaP), to analyze interactions between innovators and regulators by identifying process-process interactions. RaaP is defined by the total process of regulator's policy value chains, which includes activities upstream of technology jurisdiction, technology forecasting to technology prioritization, research and development for rule making, rule making, international harmonization, optimizing organization, draft rule operation, monitoring, and revision. Based on an analytical framework for interaction between RaaP and the innovation process, two case studies in the medical field, namely the collaborations of the US National Institutes of Health-Food and Drug Administration (NIH-FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) with innovators, were conducted to validate the process-process interaction analysis and RaaP concept.