| 引用本文: | 李文龙,门瑛璇,魏京京,吴朝阳,谭丽媛,王雪蕾,师佳,王岩,张庆生.新时代我国境外生产化学药品注册检验的变化、机遇与挑战[J].中国现代应用药学,2025,42(10):41-45. |
| liwenlong,menyingxuan,weijingjing,wuzhaoyang,tanliyuan,wangxuelei,shijia,wangyan,zhangiqngsheng.Changes, opportunities and challenges in the registration and inspection of chemical drugs produced overseas in China in the new era[J].Chin J Mod Appl Pharm(中国现代应用药学),2025,42(10):41-45. |
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| 新时代我国境外生产化学药品注册检验的变化、机遇与挑战 |
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李文龙, 门瑛璇, 魏京京, 吴朝阳, 谭丽媛, 王雪蕾, 师佳, 王岩, 张庆生
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中国食品药品检定研究院
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| 摘要: |
| 本文围绕《药品注册管理办法》构建的新时代药品注册管理体系,聚焦境外生产化学药品注册检验工作,分析其主要变化以及带来的机遇与挑战。为加深申请人和检验机构对注册检验工作的认识和理解,提升注册检验工作质量,提高注册检验工作效率,加速境外新药上市提供参考,以期让更多的新药好药获批上市惠及人民。 |
| 关键词: 新时代 境外生产化学药品 注册检验 变化 机遇与挑战 |
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| 基金项目:口岸药品检验机构技术能力评价体系建设研究（2023HYZX32）；临床急需化学药品注册检验工作机制创新研究（2019G1） |
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| Changes, opportunities and challenges in the registration and inspection of chemical drugs produced overseas in China in the new era |
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liwenlong, menyingxuan, weijingjing, wuzhaoyang, tanliyuan, wangxuelei, shijia, wangyan, zhangiqngsheng
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National institutes for food and drug control
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| Abstract: |
| This paper focuses on the new era of drug registration management system constructed by the " Drug Registration Management Measures, " focuses on the registration and inspection of chemical drugs produced overseas, and analyzes its main changes and the opportunities and challenges it brings. In order to deepen the understanding and understanding of the applicant and the inspection institution on the registration and inspection work, improve the quality of the registration and inspection work, improve the efficiency of the registration and inspection work, and provide reference for accelerating the listing of overseas new drugs, in order to make more new drugs approved for listing to benefit the people. |
| Key words: new era overseas production of chemical drug registration inspection change opportunities and challenges |
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