目的探讨《放射性药品管理办法》实施20余年以来出现的新问题,提出若干修订建议。方法分析当前国内放射性药品的定义、研发、生产和注册等几方面存在的实际操作问题。结果《放射性药品管理办法》已经无法满足新形势下监管和企业发展的需要。结论应及时修订《放射性药品管理办法》。 Objective To explore the new problems that have emerged since the implementation of “Radioactive Drug Administration Measures” for more than 20 years, and put forward some suggestions for revision. Methods The current operational problems of the definition, development, production and registration of radiopharmaceuticals in China were analyzed. As a result, “Measures for the Administration of Radioactive Drugs” can no longer meet the needs of regulatory and enterprise development in the new situation. Conclusions The Regulations on the Administration of Radioactive Drugs should be amended in time.