创新药械监管模式,助力海南自贸港发展——海南博鳌乐城临床真实世界数据应用试点五周年回顾与展望  

Innovative Regulatory Model for Pharmaceuticals and Medical Devices to Support the Development of Hainan Free Trade Port-Review and Prospect of the Fifth Anniversary of Clinical Real World Data Application Pilot in Boao Lecheng,Hainan

作　　者：谢京 徐景和 XIE Jing;XU Jing-he(The People’s Government of Hainan Province;National Medical Products Administration)

机构地区：[1]海南省人民政府 [2]国家药品监督管理局

出　　处：《中国食品药品监管》2024年第10期4-9,共6页China Food & Drug Administration Magazine

摘　　要：随着信息技术的快速发展,真实世界数据逐渐成为全球药械监管决策的重要工具。真实世界研究在药械审评审批中的作用越来越受到各国和地区监管机构的重视。2019年,国家药品监督管理局与海南省人民政府在海南博鳌乐城先行区启动真实世界数据应用试点,推动真实世界研究在药械监管决策中的应用。试点工作5年来,乐城先行区通过建立真实世界数据平台和创新研究方法,在推进真实世界证据支持药械监管决策等方面取得了突破性成果,包括发布多项真实世界研究相关指导原则,利用乐城真实世界证据支持多款创新药械产品注册上市等,促进了国际药械监管合作和医疗产业的发展,为全球真实世界研究的发展贡献中国力量。With the rapid development of information technology,real world data has gradually become an important tool for global pharmaceutical regulatory decision-making.The role of real world studies in review and approval of drugs and medical devices is increasingly valued by regulatory agencies in various countries and regions.In 2019,the National Medical Products Administration and the People's Government of Hainan Province launched a pilot program for real world data applications in the Boao Lecheng Pilot Zone in Hainan,to promote the use of real world studies in regulatory decision-making for drugs and medical devices.Over the past five years of pilot work,the Lecheng Pilot Zone has achieved breakthrough results in advancing regulatory decision-making for drugs and medical devices supported by real world evidence,through the establishment of a real world data platform and innovative research methods.This includes the release of multiple guidance principles related to real world studies,the use of Lecheng real world evidence to support the registration and listing of multiple innovative drug and medical device products,etc.These efforts have promoted international regulatory cooperation in drugs and medical devices and contributed to the development of the healthcare industry,showcasing China’s commitment to the advancement of global real world studies.

关 键 词：药械 监管决策 真实世界数据应用 试点 成果 

分 类 号：R95[医药卫生—药学]