中国药品监管的科学化进程与监管科学发展  

Scientific progress of drug regulation and development of drug regulatory science in China

作　　者：赵军宁 王军志 李波[1,2] 王辰 杨悦[4] 周思源[1,5] 秦晓岺 周乃元 蒋露 张伟 华桦 ZHAO JunNing;WANG JunZhi;LI Bo;WANG Chen;YANG Yue;ZHOU SiYuan;QIN XiaoLing;ZHOU NaiYuan;JIANG Lu;ZHANG Wei;HUA Hua(National Medical Products Administration(NMPA),National Key Laboratory of Drug Regulatory Science,Beijing 100038,China;National Institutes for Food and Drug Control,Beijing 102629,China;Chinese Academy of Medical Sciences,Beijing 100730,China;School of Pharmacy,Tsinghua University,Beijing 100083,China;Center for Drug Evaluation,National Medical Products Administration(NMPA),Beijing 100022,China;China Society for Drug Regulation,Beijing 100050,China;Sichuan Center for Translational Medicine of Traditional Chinese Medicine,Sichuan Academy of Chinese Medicine Sciences,Chengdu 610041,China)

机构地区：[1]国家药品监督管理局,药品监管科学全国重点实验室,北京100038 [2]中国食品药品检定研究院,北京102629 [3]中国医学科学院,北京100730 [4]清华大学药学院,北京100083 [5]国家药品监督管理局药品审评中心,北京100022 [6]中国药品监督管理研究会,北京100050 [7]四川省中医药科学院,四川省中医药转化医学中心,成都610041

出　　处：《中国科学：生命科学》2024年第3期507-524,共18页Scientia Sinica(Vitae)

基　　金：国家药监局“关于实施中国药品监管科学行动计划的通知(国药监科外[2019]23号)”;国家药监局综合司“中国药品监管科学行动计划分工方案的通知(药监综科外[2019]63号)”;国家药监局“关于实施中国药品监管科学行动计划第二批重点项目的通知(国药监科外[2021]37号)”;2022年度国家药品监督管理局研究课题“国家药品监管科学‘十四五’发展规划研究(2022-1121)”资助。

摘　　要：国家药品监督管理局(National Medical Products Administration,NMPA)监管职责涉及所有中国人的生命、健康和福祉,是国际上监管事务和规模最为庞大的监管机构之一,在保证创新药品、人用疫苗、医疗器械、化妆品等医疗产品的安全性和有效性方面发挥至关重要的作用.伴随着药品监管科学化进程和药品监管科学行动计划的实施,我国对全球医药研发的贡献实现了历史性跨越,正朝向建立科学、高效、权威的药品监管体系战略目标迈进.本文基于科学轨迹和里程碑事件,将中国药品监管的科学化进程分为四个阶段:起步阶段——药物分析技术应用(1949~1984),发展阶段——药品注册标准建立(1985~2014),加速阶段——监管科学理念导入(2015~2018),跨越阶段——监管科学行动计划(2019~2023).“十四五”期间,中国药品监管的科学化进程进入新的发展时期——全面强化药品监管科学体系建设的新阶段,要进一步明确监管科学发展战略目标、重点任务、优先事项及各方责任,以全国重点实验、局重点实验室、监管科学基地三大平台建设为重点,完善药品监管科学的科技创新、技术评价、成果转化、学科培育、国际协调五大体系,以化学药、中药、生物制剂、医疗器械、化妆品、新兴交叉学科产品六大监管领域“卡脖子”问题为突破口,实施一批有助于加速新兴技术产品上市和可靠地生产药品的重点项目,持续创新药品监管新工具、新方法、新标准,解决药品监管基础性、关键性、前沿性和战略性技术问题,以期获得中国式现代化药监科技领域重大突破,更好地应对科技迅猛发展、公众健康需求、监管全球化带来的危机与挑战.Regulatory responsibilities of the National Medical Products Administration involve the life,health,and welfare of all Chinese people.It is one of the largest regulatory agencies in the world in terms of regulatory affairs and scale and plays a vital role in ensuring the safety and effectiveness of innovative drugs,human vaccines,medical devices,cosmetics,and other medical products.With the scientific progress of drug regulation and implementation of the action plan of regulatory science,China’s contribution to global drug research and development has achieved a historic leap and is moving toward the strategic goal of establishing a scientific,efficient,and authoritative drug regulatory system.Based on the scientific track and milestone events,this paper divides the scientific progress of drug regulation in China into four stages:the initial stage,the application of drug analysis technology(1949–1984);the development stage,technical requirements for drug registration(1985–2014);the accelerated stage,the introduction of scientific regulatory concepts(2015–2018);and the great-leap-forward stage,the implementation of scientific regulatory action(2019–2023).The next stage is the strengthening stage,which involves comprehensively promoting regulatory science.In accordance with the overall requirements of the state for comprehensively strengthening the drug regulatory capacity,we will develop and implement a new scientific strategy for the future.

关 键 词：药品监督管理 科学化进程 监管科学 医药产业 技术创新 

分 类 号：F203[经济管理—国民经济] F426.72