放射性药物生产过程追溯体系的构建  

Exploration of the Traceability System in Radiopharmaceuticals

作　　者：周文媛 范洋 刘特立 陈卓 朱华[1] 杨志[1] ZHOU Wenyuan;FAN Yang;LIU Teli;CHEN Zhuo;ZHU Hua;YANG Zhi(NMPA Key Laboratory for Research and Evaluation of Radiopharmaceuticals(National Medical Products Administration),Department of Nuclear Medicine,Peking University Cancer Hospital&Institute,Beijing 100142,China;Bio-Platform Logistics Service Center,Beijing 100142,China)

机构地区：[1]北京大学肿瘤医院暨北京市肿瘤防治研究所核医学科国家药监局放射性药物研究与评价重点实验室,北京100142 [2]北京亦庄国际生物试剂物流中心有限公司,北京100142

出　　处：《同位素》2023年第4期416-422,共7页Journal of Isotopes

基　　金：国家自然科学基金资助项目(82171973,8217180);北京市医院管理中心“登峰”计划(DFL20191102)。

摘　　要：近几年,生物医药行业创新技术产品迭代迅速,放射性药物应运而生,迅猛发展的同时也带来一系列复杂和独特的挑战。尽管药品监管科学技术的推广实现了药品监管治理体系的规范化和药品监管事业的有效覆盖,放射性药物生产、使用及健康效应评价等方面依旧处于缺乏科学、有效、系统性监管体系的状态。聚焦我国放射性药物监管的突出问题,以市场状况、临床需求、药品技术审评等为切入点,从全过程周期管理的角度开展系统研究,对放射性药物生产过程可追溯机制体系进行探索和总结,明确监管的重点方向、基本框架和管理路径,建立符合放射性药物特性并与其发展相适应的监管体系,助力行业、产业高质量发展,切实服务于患者。In recent years,the rapid iteration of innovative technology products in the biomedical industry has given rise to the emerging field of radiopharmaceuticals,which brings with it a series of complex and distinct challenges.Although the popularization of drug regulatory science and technology has achieved the standardization of drug regulatory governance system and effectively covered drug regulatory undertakings,there remains a lack of a scientific,effective and systematic regulatory system for the production,utilization and health effect evaluation of radiopharmaceuticals.To address the prominent issues of radiopharmaceutical supervision in China,it is crucial to focus on market conditions,clinical needs,drug technical review,and other pertinent factors as key areas of concern.By conducting systematic research from the perspective of whole-process cycle management,efforts can be made to explore and summarize the traceability mechanism system for the production process of radiopharmaceuticals,and to clarify the key direction,basic framework and management path of supervision.This will facilitate the establishment of a supervision system that is in line with the characteristics of radiopharmaceuticals and adaptable to their development,thereby promoting the industrial advancement of the industry.Moreover,it will guide the domestic radiopharmaceutical field towards achieving scientific and high-quality development,effectively addressing the unmet clinical needs of patients.

关 键 词：放射性药物 监管科学 监管治理体系 健康效应评价 可追溯体系 

分 类 号：TL923[核科学技术—核燃料循环与材料] R817.9[医药卫生—影像医学与核医学]