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KMID : 1142220230180010001
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Regulatory Research on Food, Drug & Cosmetic
2023 Volume.18 No. 1 p.1 ~ p.13
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Regulatory Science: Research to Develop Evidence-based Regulations
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Lee Dae-Sung
Kwon Kyeng-Hee
Lee Jang-Ik
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Abstract
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Regulatory authorities around the world are increasingly focusing on the research and development of regulatory science with the need to develop regulations that reflect patient access to medical products and the growing demand for public health. In this context, it is important for regulatory science researchers and educators to have a proper understanding of the goals and context of regulatory science, necessitating a review of its definition, as well as research and development strategies. Unlike regulatory affairs, which is the strategic implementation of regulatory processes, regulatory science focuses on evaluation methods or criteria that generate evidence through scientific research. For regulatory science research, the FDA and the EMA have provided clear research areas through Focus Areas of Regulatory Science (FARS) and Regulatory Science Research Needs (RSRN), respectively, and have established sufficient institutions and funding for the field. In addition, programs run by the Center of Excellence in Regulatory Science and Innovation (CERSI) in the United States and the Innovative Medicines Initiative (IMI) in Europe are training professionals in regulatory science. Ministry of Food and Drug Safety (MFDS) initiated research and training program on regulatory science in 2021. To achieve the goals, it is necessary to properly understand the concept of regulatory science, develop the research areas of regulatory science by taking reference from overseas cases, and establish a system for supporting them. To this end, we propose to define and conceptualize regulatory science as follows, with the expectation that it will lead to global standards and innovation in public health and medical products. ? Regulatory science is the scientific foundations for the regulatory system through which governments regulate ? the activities of businesses, particularly those related to the public health or safety. ? Regulatory science is a field of research that is distinct from regulatory affairs, which refers to the actual ? implementation or enforcement of regulations by government or industry. ? Regulatory science is an interdisciplinary field of natural and social sciences that studies the standards or criteria ? for regulating medical products, ensuring their safety, efficacy, and reasonableness.
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KEYWORD
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Regulatory science, Regulatory affairs, Medical product, research and development strategy, evidence-based regulations
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