RADIATION PROTECTION BULLETIN ›› 2021, Vol. 41 ›› Issue (5): 44-47.

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Overview of Industry Guidelines for Radiopharmaceutical Preclinical Study

Gao Jie, Zhou Wenhua, Liu Xiaoming, Liu Huan, Wang Ruoqi, Yin Jinjin, Li Jiangguo   

  1. GLP Center,China Institute for Radiation Protection,Taiyuan,Shanxi 030006
  • Received:2021-08-26 Online:2021-10-20 Published:2022-03-31

Abstract: We introduce radiopharmaceutical regulatory management systems in the United States,Europe and China,describe the process of applying for clinical study of radiopharmaceuticals in China,and compare the legal and regulatory differences and similarities in China with Europe and America in the respect.

Key words: Radiopharmaceuticals, Preclinical study, Regulatory management system

CLC Number: 

  • R818