我国放射性药品检验能力与需求调查分析研究  

Investigation and Analysis on the Testing Capacity and Demand of Radiopharmaceuticals in China

作　　者：李文龙 贾娟娟[1] 张文在 孙得洋 刘燕[1] 姚静[1] 王岩[1] 黄海伟[1] Li Wenlong;Jia Juanjuan;Zhang Wenzai;Sun Deyang;Liu Yan;Yao Jing;Wang Yan;Huang Haiwei(National Institutes for Food and Drug Control,NMPA Key Laboratory for Research and Evaluation of Radiopharmaceuticals,NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs,State Key Laboratory of Drug Regulatory Science,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,国家药品监督管理局放射性药物研究与评价重点实验室,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,药品监管科学全国重点实验室,北京102629

出　　处：《中国药事》2024年第11期1275-1281,共7页Chinese Pharmaceutical Affairs

基　　金：放射性药品检验实验室能力建设规范(编号2023HYZX31)。

摘　　要：目的:深入了解我国现阶段放射性药品的检验能力和检验需求,为我国放射性药品检验机构建设和能力提升提供参考。方法:采用调查问卷的形式,对药品检验机构、放射性药品生产单位、制备正电子类放射性药品的医疗机构进行调查,结合各机构特点分别设计问卷,主要涉及基本情况、建设意愿、在产和在研品种情况、质控能力和委托外单位检验情况、需检验机构协助解决的问题、对新增国家放射性药品检验机构的建议等,并对调查结果进行统计分析。结果:根据29个省、自治区、直辖市反馈的122份反馈问卷显示,广东、山东、江苏等地所属的省级药品检验机构建设意愿较强。生产单位和医疗机构在产主要品种为锝[99mTc]标记药物和氟[18F]脱氧葡糖注射液,镥[177Lu]、镓[68Ga]等新型核素放药研发增多,注射剂仍为主要研发使用剂型。均建议新建国家放射性药品检验机构。结论:目前,我国放药生产单位和医疗机构研发热情高涨,检验需求旺盛,但自检能力较弱,建议国家合理布局放射性药品检验机构,加强检验能力建设,同时开展重点品种和剂型的质量控制研究,促进质量标准提升,服务产业发展。Objective:To gain an in-depth understanding of the testing capacity and testing demand of radiopharmaceuticals at the present stage in China,and to provide reference for the construction and capacity enhancement of radiopharmaceutical inspection institution in China.Methods:A questionnaire was used to investigate the pharmaceutical testing institution,radiopharmaceutical production units,and medical institutions preparing positronic radiopharmaceuticals,and the questionnaires were designed in combination with the characteristics of each institution,mainly involving the basic situation,the willingness to build,the situation of the varieties in production and research,the quality control capacity and the commissioning of external testing,the problems that need to be solved with the assistance of testing organizations,the suggestions for the new national radiopharmaceutical testing organizations,etc.The results of the survey were statistically analyzed.Results:According to the 122 feedback questionnaires returned from 29 provinces,autonomous regions and municipalities directly under the central government,the willingness to build provincial-level drug testing institution belonging to Guangdong,Shandong,Jiangsu and other regions was relatively strong.The main varieties producted by production units and medical institutions were technetium[99mTc]labeled drugs and fludeoxyglucose[18F]injection.The reasearch and development of new nuclide radiopharmaceaticals such as lutetium[177Lu],gallium[68Ga]were increased,and injection was still the main research and development of the use of dosage forms.It is recommended to build a new national radiopharmaceutical testing organization.Conclusion:At present,China's radiopharmaceutical production units and medical institutions have high enthusiasm for research and development,strong demand for testing,but the self-test capacity is weak,it is recommended that the state rationalize the distribution of radiopharmaceutical testing institutions,strengthen the construction of testing cap

关 键 词：放射性药品 检验能力 检验需求 调查问卷 监管科学 

分 类 号：R95[医药卫生—药学]