我国放射性药品监管法规体系研究三:我国放射性药品监管要素与行业痛点的体系性研究  

Research Ⅳ on China's Radiopharmaceutical Regulatory System:Suggestions on Improving China's Radiopharmaceutical Regulatory System

作　　者：须星 张晔 刘爽 吴小艳 屈巧玲[5] 马伟伟 李拓 吕欣 陈江鹏 刘慧慧 霍秀敏 杨建红 葛强 王鹏 武志昂 Xu Xing;Zhang Ye;Liu Shuang;Wu Xiaoyan;Qu Qiaoling;Ma Weiwei;Li Tuo;Li Xin;Chen Jiangpeng;Liu Huihui;Huo Xiumin;Yang Jianhong;Ge Qiang;Wang Peng;Wu Zhi'ang(Nanjing Congyi Medical Consulting Co.,Ltd.,Nanjing 210000,China;Beijing Huixiang Pharmaceutical Technology Co.,Ltd.,Beijing 102206,China;Beijing Sinotau Intl.Pharmaceutical Technology Co.,Ltd.,Beijing 100176,China;Wuhan Shetai Medical Technology Co.,Ltd.,Wuhan 430033,China;Bayer Healthcare Co.,Ltd.,Beijing 100020,China;Yantai LNC Biotechnology Co.,Ltd.,Yantai 264006,China;Peking Union Medical College Hospital,Chinese Academy of Medical Sciences,Beijing 100730,China;Yeehong Business School,Beijing 100055,China;Center for Drug Evaluation,National Medical Products Administration,Beijing 100076,China;Chengdu New Radiomedicine Technology Co.,Ltd.,Chengdu 610200,China)

机构地区：[1]南京从一医药科技有限公司,南京210000 [2]北京荟想医药科技有限公司,北京102206 [3]北京先通国际医药科技股份有限公司,北京100176 [4]武汉社泰医疗科技有限公司,武汉430033 [5]拜耳医药保健有限公司,北京100020 [6]烟台蓝纳成生物技术有限公司,烟台264006 [7]中国医学科学院北京协和医院,北京100730 [8]亦弘商学院,北京100055 [9]国家药品监督管理局药品审评中心,北京100076 [10]成都纽瑞特医疗科技股份有限公司,成都610200

出　　处：《中国药事》2025年第1期23-33,共11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:系统梳理建立我国放射性药品全生命周期的监管要素和对应的行业痛点,为推进我国放射性药品的健康发展提供参考。方法:采用文献研究、比较研究方法并结合行业实践,在分析国内外放射性药品行业发展现状、趋势和监管体系的基础上,初步建立起关于我国放射性药品全生命周期的监管要素与行业痛点体系草案。采用非概率抽样法开展问卷调研,同时开展针对性的专家研讨与访谈,进一步确认该体系草案的完整性、科学性,识别阻碍放射性药品发展的行业痛点,以探索解决策略。结果与结论:梳理建立的体系共由四级组成,分别为管理环节6个、一级监管要素16项、二级监管要素41项和行业痛点问题53个。根据问卷调研和专家研讨与访谈的结果,表明该体系较为完整、准确,对于进一步提出相关建议具有参考价值。Objective:To provide a reference for improving the regulatory system of radiopharmaceutical in China.Methods:The particularities,regulatory elements and pain points of all aspects of whole life cycle of radiopharmaceuticals were sorted out,and suggestions were put forward by comparing the domestic and foreign regulatory literatures and combining with comprehensively analysis of expert discussions and interviews as well as questionnaire inquiries.Results and Conclusion:Based on the particularity of radiopharmaceuticals,suggestions were put forward on improving the radiopharmaceutical regulatory system in China,including general suggestions on legal and regulatory frameworks,and the regulatory suggestions at each aspect of the whole life cycle such as research and development,registration,production,circulation,use and environmental impact assessment.

关 键 词：放射性药品 监管要素 行业痛点 全生命周期管理 问卷调研 

分 类 号：R95[医药卫生—药学]