Chinese Journal of Pharmacovigilance ›› 2025, Vol. 22 ›› Issue (1): 37-42.
DOI: 10.19803/j.1672-8629.20240570

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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

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

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