The concept of regulatory frontier as a boundary of jurisdiction in medicine — A case of regenerative medicine in Japan

A proposed framework using the concept of "Regulatory Frontier" which describes decreasing of capability threshold for making the rules along with the maturation of technology provides a new method to define "Regulatory Space." The Regulatory Frontier could divide regulatory space into "on the rule space" and "off the rule space," and explains why regulation inevitably delays against innovation. When technological development progresses at the point of maturity that needs the rule or regulation for clinical development for medical applications without the rule and the technical standard to utilize it, the technology is in the "off the rule space" and falls into the "regulatory gap." To explain this phenomenon and also discuss the interaction between innovation and regulation, the author introduces a case study of regulatory activities in Japanese regenerative medicine and then theorizes "regulatory gap" and rationalize the alternative path which so called hospital exception with some additional emerging rules in Japan to provide the authorized new therapy to the patients.