中国食品药品监管Issue(5)：60-67,8.DOI:10.3969/j.issn.1673-5390.2025.05.006
监管科学研究对美国再生医学决策支持途径分析
Analysis of Regulatory Scientific Research on Decision-Making Support Pathways for Regenerative Medicine in the U.S
摘要
Abstract
Objective:This study takes the U.S.Food and Drug Administration(FDA)as a case to explore how academic research supports regulatory decision-making in the field of regenerative medicine,aiming to improve the effectiveness of such support.Methods:A bibliometric methods analysis was conducted from three perspectives:research collaboration,knowledge support,and project funding.Results:The FDA engages in extensive internal collaborations as well as partnerships with other government agencies,universities,and enterprises.These collaborators are not only limited to the U.S.-based institutions,but also include partners from Japan,the United Kingdom,China,and other countries.The knowledge base supporting FDA research is primarily domestic,followed by contributions from China,Germany,the United Kingdom,and Italy.The dominant disciplines include cell biology,biomedical engineering,and cell and tissue engineering,with publications primarily in Q1 and Q2 journals.The FDA independently funds relatively few regenerative medicine projects;most are co-funded with other institutions and focuses on topics such as cell model construction,amplification,differentiation,and expression.Conclusion:Supporting regulatory science decision-making requires active international collaboration,greater industry involvement,a focus on specialized topics and high-impact journals,and-when feasible-collaborative or commissioned research with regulatory bodies.关键词
决策支持/监管科学/美国食品药品监督管理局/再生医学/文献计量学Key words
decision-making support/regulatory science/U.S. Food and Drug Administration(FDA)/regenerative medicine/bibliometrics分类
医药卫生引用本文复制引用
严舒,张婷,欧阳昭连..监管科学研究对美国再生医学决策支持途径分析[J].中国食品药品监管,2025,(5):60-67,8.基金项目
中国医学科学院医学与健康科技创新工程项目(2021-I2M-1-056) （2021-I2M-1-056）
国家自然科学基金项目(L1924064) （L1924064）
