규제과학의 개념과 발전전략: 식품, 의약품, 의료기기를 중심으로

Abstract

Science areas related to evaluating the safety, efficacy, performance, and quality of a product can be referredto 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 developRS in South Korea. We reviewed the literature and the websites of foreign regulatory bodies to determine thecharacteristics and development strategies of RS for drugs, medical devices, and foods. To understand the current statusof 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 studydiscusses the characteristics of regulatory science in a specific context; the term RS has been used to mean “regulatoryaffairs” in Korean non-academic contexts. Seven types of structures were identified as fostering RS: a regulatory bodysupporting designated institutions, a partnership for research, networks of regulatory bodies, an RS center established by agovernment agency, a government agency dedicated for RS, an RS center established in a university, and individualuniversity programs. Healthcare issues and available technology are important factors in deciding focus research areas. Thisstudy reviewed various aspects of RS and its current status in Korea to facilitate decisions on Korean RS developmentstrategy.