中国药物警戒 ›› 2025, Vol. 22 ›› Issue (1): 37-42.
DOI: 10.19803/j.1672-8629.20240570

• 放射性药品监管科学研究专栏 • 上一篇    下一篇

我国放射性药品发展现状与展望

李文龙1,2,3,4, 贾娟娟1,2,3,4, 黄海伟1,2,3,4, 姚静1,2,3,4, 张春青4,5, 王岩4,6,*, 张辉4,7#   

  1. 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
  • 收稿日期:2024-08-12 出版日期:2025-01-15 发布日期:2025-01-22
  • 通讯作者: *王岩,男,硕士,副主任药师,仪器设备管理与药品质量控制。E-mail: rock@nifdc.org.cn#为共同通信作者。
  • 作者简介:李文龙,男,硕士,主管药师,药品监管科学与放射性药品质量控制。
  • 基金资助:
    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）

Developments and Prospects of Radiopharmaceuticals in China

LI Wenlong1,2,3,4, JIA Juanjuan1,2,3,4, HUANG Haiwei1,2,3,4, YAO Jing1,2,3,4, ZHANG Chunqing4,5, WANG Yan4,6,*, ZHANG Hui4,7#   

  1. 1National Institutes for Food and Drug Control Institute for Chemical Drug Control, Beijing 102629, China;
    2NMPA Key Laboratory for Research and Evaluation of Radiopharmaceuticals, Beijing 102629, China;
    3NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs, Beijing 102629, China;
    4State Key Laboratory of Drug Regulatory Science, Beijing 102629, China;
    5National Institutes for Food and Drug Control Institute of Medical Device Standardization Administration, Beijing 102629, China;
    6National Institutes for Food and Drug Control Department of Equipment Management, Beijing 102629, China;
    7National Institutes for Food and Drug Control Department of General Office, Beijing 102629, China
  • Received:2024-08-12 Online:2025-01-15 Published:2025-01-22

PDF (PC)

44

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。

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

Abstract: 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.

Key words: Radiopharmaceuticals, High-Quality Develo-pment, Pharmaceutical Inspection Organization, Develo-pment Status, Research and Development, Supervision and Management, Regulatory Science

中图分类号: