海南博鳌乐城先行区真实世界研究统筹“研-评-产”相结合的创新发展模式  

Real-World Study of Hainan Boao Lecheng International Medical Tourism Pilot Zone:Coordinating the Innovative Development Model of“Research-Evaluation-Production”

作　　者：高玉欣 常丽梅 黄凌 GAO Yu-xin;CHANG Li-mei;HUANG Ling(Hainan Center for Drug and Medical Device Evaluation and Service;Center for Pharmacovigilance of Hainan Province)

机构地区：[1]海南省药品和医疗器械审评服务中心 [2]海南省药物警戒中心

出　　处：《中国食品药品监管》2024年第10期34-41,共8页China Food & Drug Administration Magazine

基　　金：海南省自然科学基金面上项目(821MS153);海南省博鳌乐城先行区真实世界研究专项计划项目(HNLC2022RWS006);海南省重点研发项目(ZDYF2023SHFZ121)。

摘　　要：本文总结了海南博鳌乐城国际医疗旅游先行区特许药品和医疗器械真实世界研究试点应用基本情况,探讨了乐城先行区真实世界研究的监管制度体系和研究进展,及其在“研-评-产”相结合的创新发展模式中的作用。乐城先行区开展临床真实世界数据应用,降低了临床试验的经济成本,缩短了药械研发时限,推动了临床急需进口药械和已在境外上市的全球创新药械在国内的上市进程,惠及了更广大的患者人群。同时,乐城先行区为利用真实世界证据支持药品、医疗器械监管决策的方法提供了全新的视角和路径,探索出了先进药械“研-评-产”创新发展模式。此外,真实世界数据应用试点为进一步拓展真实世界数据应用范围积累了宝贵经验,试点经验具有一定的推广应用潜力。This paper summarizes the basic situation of real-world research and application of licensed drugs and medical devices in Hainan Boao Lecheng International Medical Tourism Pilot Zone(Lecheng Pilot Zone).It discusses the regulatory system and research progress of real-world studies in Lecheng Pilot Zone,as well as their role in the innovative development model of"research-evaluation-production".The application of clinical real-world data in the Lecheng Pilot Zone has reduced the economic costs of clinical trials,shortened the research and development timelines for drug devices,and promoted the domestic approval process for urgently needed imported drugs and global innovative drug devices already approved overseas,benefiting a wider range of patients.Meanwhile,the Lecheng Pilot Zone provides a new perspective and pathway for using real-world evidence to support regulatory decision-making for drugs and medical devices,exploring an innovative development model of"research-evaluation-production"for advanced pharmaceutical devices.In addition,the pilot project in Hainan has accumulated valuable experience for further expanding the application scope of real-world data,with the potential for broader promotion and application.

关 键 词：乐城先行区 真实世界研究 特许药品和医疗器械 监管体系 创新发展模式 

分 类 号：R95[医药卫生—药学]