我国放射性药品监管法规体系研究一:我国放射性药品发展现状及分析  

Research I on China's Radiopharmaceutical Regulatory System:China's Radiopharmaceutical Development Status and Analysis

作　　者：傅洁 刘爽 王玉坤 龚焱 吕心欢 王鹏 张晔 Fu Jie;Liu Shuang;Wang Yukun;Gong Yan;LüXinhuan;Wang Peng;Zhang Ye(Bayer Healthcare Co.,Ltd.,Beijing 100020,China;Beijing Sinotau Intl.Pharmaceutical Technology Co.,Ltd.,Beijing 100176,China;Shanghai Honghong Pharmaceutical Consulting Co.,Ltd.,Shanghai 201200,China;Yeehong Business School,Beijing 100055,China;Beijing Huixiang Pharmaceutical Technology Co.,Ltd.,Beijing 102206,China)

机构地区：[1]拜耳医药保健有限公司,北京100020 [2]北京先通国际医药科技股份有限公司,北京100176 [3]上海闳泓医药咨询有限公司,上海201200 [4]亦弘商学院,北京100055 [5]北京荟想医药科技有限公司,北京102206

出　　处：《中国药事》2025年第1期1-12,共12页Chinese Pharmaceutical Affairs

基　　金：中国药品监督管理研究会委托亦弘商学院开展的“我国放射性药品监管法规体系研究”课题(编号2022-Y-Y-001)。

摘　　要：目的:为完善我国放射性药品监管法规体系建设,促进放射性药品产业发展,满足临床用药需求,本文系统梳理了国内放射性药物发展现状及面临的挑战。方法:采用文献研究法并结合工作实践,对比国内外放射性药物产业发展的差异,分析国内放药行业面临的主要问题。结果与结论:我国放射性药物产业发展虽已取得长足进步,但仍面临诸多困难与挑战,主要包括放射性药物专业人才缺口较大,核素供应仍大量依赖进口,市场规模与临床需求之间存在差距,监管政策与技术指导原则尚需完善和细化等。Objective:To improve the regulatory system for radiopharmaceuticals,promote the development of the radiopharmaceuticals industry,and meet the needs of clinical medication,by reviewing the current situation and challenges of the development of domestic radiopharmaceuticals.Methods:Using literature research method and combined with work practice,this paper compared the differences in the development of the radiopharmaceutical industry at home and abroad,and analyzed the main problems faced by the domestic radiopharmaceutical industry.Results and Conclusion:Although China's radiopharmaceutical industry has made significant progress,it still faces many difficulties and challenges,mainly including a large shortage of radiopharmaceutical professionals,a heavy reliance on imports for nuclide supply,a gap between market size and clinical demand,and the need to improve and refine regulatory policies and technical guidance principles.

关 键 词：放射性药品 核素诊断 核素治疗 中国放射性药物产业 

分 类 号：R95[医药卫生—药学]