| 匡岩巍,杜建冬,杜婧,程缤雁,张云.新《药品管理法》实施后放射性药品监管法规的变化及对策分析[J].中国药事,2023,(6):659-663 |
| 新《药品管理法》实施后放射性药品监管法规的变化及对策分析 |
| Changes and Countermeasure Analysis of Radiopharmaceuticals Regulatory Regulations after the Implementation of the New “Pharmaceutical Administration Law” |
| 投稿时间：2022-05-23 |
| DOI：10.16153/j.1002-7777.2023.06.004 |
| 中文关键词: 放射性药品 药品管理法 变化 管理模式 对策 |
| 英文关键词: |
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| 摘要点击次数: 1209 |
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| 中文摘要: |
| 目的：阐明新修订《中华人民共和国药品管理法》(以下简称《药品管理法》)实施后放射性药品监管法规的主要变化，为放射性药品监管和放射性药品相关企业提供参考。方法：依据《药品注册管理办法》《药品生产监督管理办法》《放射性药品管理办法》以及相关制度的新要求，对影响放射性药品监管的主要变化进行总结和分析。结果与结论：新修订《药品管理法》落实以人为本的理念，加强了对放射性药品全生命周期的监管的同时，调动了放射性药品市场的积极性，促进了上市许可持有人管理能力的提升和主体责任的落实。 |
| 英文摘要: |
| Objective: This paper aims to clarify the major changes of radiopharmaceuticals regulatory regulations after the implementation of the new version “Pharmaceutical Administration Law of the People's Republic of China” (Hereinafter referred to as the “Pharmaceutical Administration Law”), so as to provide reference for radiopharmaceuticals regulatory and radiopharmaceuticals related enterprises. Methods: According to the new requirements of provisions for drug registration, drug production supervision and administration measures, radiopharmaceuticals administration measures and related systems, the main changes affecting the supervision and administration of radiopharmaceuticals were summarized and analyzed. Results and Conclusions: The new version of The “Pharmaceutical Administration Law” implemented the people-oriented concept, strengthened the supervision of the whole life cycle of radioactive drugs, and at the same time aroused the enthusiasm of the radioactive drugs market, promoted the management ability and the implementation of the main responsibility of the marketing authorization holders. |
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