Korean Journal of Clinical Pharmacy (한국임상약학회지)

Korean College Of Clinical Pharmacy (한국임상약학회)
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Analysis of Trends in Regulatory Science and Regulatory Science Experts Training Projects: US, Japan, Singapore, and Korea

규제과학 및 규제과학 전문가 양성 프로젝트의 국내외 동향분석: 미국, 일본, 싱가포르, 한국을 중심으로

  • Park, Jaehong (Department of Pharmaceutical Industry, Chung-Ang University) ;
  • Shin, Hocheol (Department of Pharmaceutical Industry, Chung-Ang University) ;
  • Kim, Jiwon (Department of Pharmaceutical Industry, Chung-Ang University) ;
  • Kim, Minsu (Department of Pharmaceutical Industry, Chung-Ang University) ;
  • Do, In Gu (Department of Pharmaceutical Industry, Chung-Ang University) ;
  • Lim, Heeyeon (Department of Pharmaceutical Industry, Chung-Ang University) ;
  • Lee, Jiwon (Department of Pharmaceutical Industry, Chung-Ang University) ;
  • Lee, Yun-ji (College of Pharmacy, Chung-Ang University) ;
  • Jung, Sun-Young (Department of Pharmaceutical Industry, Chung-Ang University) ;
  • Kang, Wonku (College of Pharmacy, Chung-Ang University) ;
  • Kim, Hahyung (College of Pharmacy, Chung-Ang University) ;
  • Choi, Young Wook (Department of Pharmaceutical Industry, Chung-Ang University) ;
  • Kim, Eunyoung (Department of Pharmaceutical Industry, Chung-Ang University)
  • 박재홍 (중앙대학교 제약산업학과) ;
  • 신호철 (중앙대학교 제약산업학과) ;
  • 김지원 (중앙대학교 제약산업학과) ;
  • 김민수 (중앙대학교 제약산업학과) ;
  • 도인구 (중앙대학교 제약산업학과) ;
  • 임희연 (중앙대학교 제약산업학과) ;
  • 이지원 (중앙대학교 제약산업학과) ;
  • 이윤지 (중앙대학교 약학대학) ;
  • 정선영 (중앙대학교 제약산업학과) ;
  • 강원구 (중앙대학교 약학대학) ;
  • 김하형 (중앙대학교 약학대학) ;
  • 최영욱 (중앙대학교 제약산업학과) ;
  • 김은영 (중앙대학교 제약산업학과)
  • Received : 2021.11.02
  • Accepted : 2021.12.01
  • Published : 2021.12.31
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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.

Keywords

Acknowledgement

이 논문은 2021년도 정부(교육부)의 재원과 Ministry of Science and ICT의 재원을 받아 한국연구재단의 지원을 받아 수행된 기초연구사업임(No. 2021R1A6A1A03044296, NRF-2021R1F1A1062044).

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