A Metasystem Approach to Regulatory Rule Making on Advanced Medicine
- Shingo KANO
Professor, Graduate School of Frontier Sciences, The University of Tokyo
(1) The concept design of Regulatory Horizon Scanning
To provide timing information for guideline making to both innovators and regulators, the indicators for regulation as a regulatory horizon scanning will be developed using the grant-metrics approach and checked its validities in several technological fields.
(2) Introduction of the “Guideline of Guidelines” concept in Japanese Regulatory Framework
To improve the efficacy and transparency in the process of guideline formation for emerging evaluation technologies, we will provide the cases in both US and Japan and examine the possibilities for introducing a “rule of rules” type guideline into Japanese regulatory framework.
(3) Design of a new type of boundary organization for emerging technologies
A stakeholder management for emerging technologies and intermediation for it is a critical issue. We will design a new type of boundary organization for a sample technology as a think tank and try to manage agenda for it through the conference design.
By defining the interaction between the innovation process and the regulation process and analyzing the interaction systematically, this project pursues the improved total design of a regulatory rule making system with implementing missing functions in the Japanese regulatory framework.
For this purpose, we set three elements for the system improvement in the project;
1) Technology forecasting for regulatory activities
2) Guidance for Rule making
3) Enhancement of innovator?regulator interaction through a new type of boundary organization
In addition, we will also pursue the generalization of our approach to other technological field than medicine, and provide the experiences and implications in the co-work between policy researches and policy makers.