pISSN 1226-6051
eISSN 2508-786X

Table. 1.

Table. 1.

Regulatory Science Definitions by Country

Regulatory agency Definition
US FDA11) Regulatory Science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of some FDA-regulated products.
Japan PMDA13),19) 1) The Science that provides appropriate prediction, evaluations, and judgments to incorporate the outcomes of technology into the most desirable form for people and society (Basic Program for Science and Technology [approved by the Cabinet on August 19 2011]*)
2) The science of prediction, evaluating, and determining, fairly and promptly, efficacy, and safety of pharmaceuticals, medical devices, and regenerative medicine products, based on scientific knowledge.
EU EMA20) The range of scientific disciplines that are applied to the quality safety and efficacy assessment of medicinal products and that inform regulatory decision making throughout the lifecycle of a medicine. It encompasses basic and applied biomedical and social sciences and contributes to the development of regulatory standards and tools.
Korea MFDS13) The science of developing all tools, standards, and evaluation methods used in regulatory decisions, from evaluating the safety, effectiveness, and quality performance of products that require government regulation to the use of permits.

FDA, Food and Drug Administration; PMDA, Pharmaceuticals and Medical Devices Agency; EMA, European Medicines Agency; MFDS, Ministry of Food and Drug Safety

*https://www.mhlw.go.jp/english/policy/health-medical/pharmaceuticals/dl/140729-01-01.pdf

Korean J Clin Pharm 2021;31:257-67 https://doi.org/10.24304/kjcp.2021.31.4.257
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