Regulatory Science: Definition and Development Strategy

Abstract

Science areas related to evaluating the safety, efficacy, performance, and quality of a product can be referred to as regulatory science (RS). The Korean government recently announced plans to foster its regulatory capacity for drugs, medical devices, and foods. This study aims to clarify the characteristics of RS and their implications for how to develop RS in South Korea. We reviewed the literature and the websites of foreign regulatory bodies to determine the characteristics and development strategies of RS for drugs, medical devices, and foods. To understand the current status of RS in Korea, we reviewed the usage of the term “regulatory science” in academic literature and non-academic context. RS is a multidisciplinary science of a predictive nature that deals with uncertainty. In Korea, only one recent study discusses the characteristics of regulatory science in a specific context; the term RS has been used to mean “regulatory affairs” in Korean non-academic contexts. Seven types of structures were identified as fostering RS: a regulatory body supporting designated institutions, a partnership for research, networks of regulatory bodies, an RS center established by a government agency, a government agency dedicated for RS, an RS center established in a university, and individual university programs. Healthcare issues and available technology are important factors in deciding focus research areas. This study reviewed various aspects of RS and its current status in Korea to facilitate decisions on Korean RS development strategy.