我国放射性药品发展现状与展望  

Developments and Prospects of Radiopharmaceuticals in China

作　　者：李文龙 贾娟娟 黄海伟 姚静 张春青 王岩[4,6] 张辉 LI Wenlong;JIA Juanjuan;HUANG Haiwei;YAO Jing;ZHANG Chunqing;WANG Yan;ZHANG Hui(National Institutes for Food and Drug Control Institute for Chemical Drug Control,Beijing 102629,China;NMPA Key Laboratory for Research and Evaluation of Radiopharmaceuticals,Beijing 102629,China;NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs,Beijing 102629,China;State Key Laboratory of Drug Regulatory Science,Beijing 102629,China;National Institutes for Food and Drug Control Institute of Medical Device Standardization Administration,Beijing 102629,China;National Institutes for Food and Drug Control Department of Equipment Management,Beijing 102629,China;National Institutes for Food and Drug Control Department of General Office,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院化学药品检定所,北京102629 [2]国家药品监督管理局放射性药物与评价重点实验室,北京102629 [3]国家药品监督管理局化学药品质量研究与评价重点实验室,北京102629 [4]药品监管科学全国重点实验室,北京102629 [5]中国食品药品检定研究院医疗器械标准管理研究所,北京102629 [6]中国食品药品检定研究院仪器设备管理中心,北京102629 [7]中国食品药品检定研究院办公室,北京102629

出　　处：《中国药物警戒》2025年第1期37-42,共6页Chinese Journal of Pharmacovigilance

基　　金：国家科技重大专项重大新药创制(2017zx09101001);放射性药品检验实验室能力建设规范(2023HYZX31)。

摘　　要：目的为加快构建新发展格局,保障人民健康优先发展战略,全方位了解我国放射性药品发展的现状,对制约放射性药品生产和使用的主要问题进行分析。方法深入我国放射性药品产业集中的地区,从药品检验机构、生产单位和医疗机构的角度,采用实地走访、查阅文献、对比研究等方法开展研究。结果与结论建议加快修订《放射性药品管理办法》,规范放射性药品医疗器械审批管理,强化放射性药品检验机构建设和能力提升,加强放射性药品研发指导,加大政策引导,推进我国放射性药品产业健康、快速、高质量发展。Objective To find out about the overall development of radiopharmaceuticals in China and analyze the major obstacles to the production and use of radiopharmaceuticals.Methods In-depth studies were carried out where the radiopharmaceutical industry was concentrated in China,involving drug inspection organizations,manufacturers and medical institutions and based on field visits,literature review and a comparative study.Results and Conclusion It is recommended that the Measures for the Administration of Radiopharmaceuticals be revised as soon as possible,the approval and management of radiopharmaceuticals and medical devices be standardized,radiopharmaceutical testing institutions be upgraded,guidance on research and development of radiopharmaceuticals be increased,so as to promote the healthy,rapid and high-quality development of China’s radiopharmaceutical industry.

关 键 词：放射性药品 高质量发展 药品检验机构 发展现状 研发 监督管理 监管科学 

分 类 号：R954[医药卫生—药学]