美国食品药品管理局药品监管科学战略规划及对我国药品监管的启示  

FDA’s strategic plan for regulatory science and its implications for drug regulation in China

作　　者：张雅娟 杜鑫 张怡[3] ZHANG Ya-juan;DU Xin;ZHANG Yi(School of Pharmaceutical Sciences,Tsinghua University,BEIJING 100084,China;NMPA Key Laboratory For Research and Evaluation of Innovative Drug,BEIJING 100084 China;Vanke School of Public Health,Tsinghua University,BEIJING 100084,China)

机构地区：[1]清华大学药学院,北京100084 [2]国家药品监督管理局创新药物研究与评价重点实验室,北京100084 [3]清华大学万科公共卫生与健康学院,北京100084

出　　处：《中国新药与临床杂志》2025年第3期161-167,共7页Chinese Journal of New Drugs and Clinical Remedies

基　　金：国家社会科学基金(20CFX018);清华大学万科公共卫生与健康学院万科支柱项目(2024)。

摘　　要：美国食品药品管理局(FDA)作为全球首个将监管科学纳入其监管战略的药品监管机构,在药品监管科学体系建设方面的经验对国际社会具有重要的参考价值。FDA致力于维持监管工作的前瞻性和先进性,强调夯实监管科学的基础,并根据公众健康的实际需求和科学技术的最新发展,对其药品监管战略规划和优先发展领域进行动态调整。FDA通过“推进监管科学”和“应用监管科学”两大主要路径,不断开发和应用新工具、新标准和新方法,以应对药品监管领域的新挑战,更有效地保障公众健康。目前,我国药品监管科学建设正处于发展阶段,建议我国应尽快建立系统化的药品监管科学战略规划与评估机制,强化数据整合与应用,加强公众与患者参与,推动跨部门和跨行业的监管协作,促进人才培养和跨学科合作,并构建稳定的资金保障机制,从而推动我国药品监管科学向纵深发展。The U.S.Food and Drug Administration(FDA),as the first drug regulatory agency in the world to incorporate regulatory science into its overarching regulatory strategy,provides a significant precedent for the international community with its experience in establishing the regulatory science discipline.FDA is committed to maintaining forward-looking and cutting-edge regulatory practices by emphasizing a robust foundation in regulatory science.Moreover,the agency dynamically adjusts its strategic plans and priority areas for drug regulation based on actual public health needs and the latest science and technology developments.FDA continuously develops and applies new tools,standards,and methods through two major pathways of“advancing regulatory science”and“adopting advances in regulatory science”to address new challenges in drug regulation and more effectively safeguarding public health.At present,China’s drug regulatory science is in an early stage of development,and it is proposed that China should establish a systematic strategic plan and evaluation mechanism for drug regulatory science,strengthen data integration and application,enhance public and patient engagement,promote inter-agency and cross-industry regulatory collaboration,reinforce talent cultivation and interdisciplinary cooperation,and build a stable funding mechanism,so as to promote the in-depth development of drug regulatory science in China.

关 键 词：药品监管 监管科学 战略规划 优先发展领域 

分 类 号：R95[医药卫生—药学]