Analysis of Trends in Regulatory Science and Regulatory Science Experts Training Projects: US, Japan, Singapore, and Korea

Abstract

Background:The need for regulatory science development to evaluate advanced regulatory products is gradually increasing without hindering the technological development. Creating a research environment and fostering experts through the establishment of regulatory agency-led policies are essential for the development of regulatory science. Method: This is a comparative study of the United States, Japan, Singapore, and Korea. The literature and websites of each regulatory agency were reviewed, and the focus was on advantages and comparing advantages based on definition, development trends, and expert training projects. Results: The United States is striving to develop regulatory science in response to changes in the new pharmaceutical industry through the regulatory science report, and to foster expert both inside and outside the Food and Drug Administration (FDA). Japan is promoting regulatory science centered on regulatory science centers, and is focusing on researching work-related regulatory science within the Pharmaceuticals and Medical Devices Agency (PMDA) and improving employees' ability to make regulatory decisions. Singapore was aiming to improve Southeast Asia's regulatory capabilities under the leadership of Centre of Regulatory Excellence (CoRE) within Duke-NUS University. In 2021, Korea is in its early stages, starting to run a university's degree program related to regulatory science this year. Conclusion: Regulatory science should be developed with the aim of improving the regulatory ability of the Ministry of Food and Drug Safety with Korea's independent concept of regulatory science.

Application of implementation science framework to develop and adopt regulatory science in different national regulatory authorities

“…The policymakers make use of this approach, which ensures that decision-making is well-informed by the best available research evidence, for systematic and transparent access to evidence as a prerequisite for the process of policymaking ( 76 , 77 ). Adopting RS to obtain scientific evidence and apply it in the decision-making process has been used by many governments ( 78 – 80 ). It has been found that providing regulators with the resources, knowledge, and evidence they need for the decision-making process helps to improve their identification of the most pressing practical social needs and strengthen their regulatory capacity ( 81 , 82 ).…”