| 对我国附条件批准上市化药药学技术要求的思考 |
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| 引用本文： | 赵一飞,耿欣,徐立华,欧婷,张宁.对我国附条件批准上市化药药学技术要求的思考[J].中国药科大学学报,2021,52(5):636-642. |
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| 作者姓名： | 赵一飞 耿欣 徐立华 欧婷 张宁 |
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| 作者单位： | 国家药品监督管理局药品审评中心，北京 100022,国家药品监督管理局药品审评中心，北京 100022,国家药品监督管理局药品审评中心，北京 100022,国家药品监督管理局药品审评中心，北京 100022,国家药品监督管理局药品审评中心，北京 100022 |
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| 摘 要： | 我国2019年修订的《药品管理法》首次在法律层面提出附条件批准上市，标志着我国正式实施附条件批准上市制度。本文通过比较我国与欧美地区附条件批准上市药品的法规与技术要求，借鉴欧美地区对附条件批准化学药品的药学审评经验，探讨我国附条件批准上市化学药品的药学审评技术要求。
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| 关 键 词： | 化学药品 附条件批准 药学 技术要求 |
| 收稿时间： | 2021/4/3 0:00:00 |
| 修稿时间： | 2021/9/6 0:00:00 |
Considerations on the chemistry, manufacture and control requirements for conditional marketing authorization drugs in China |
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| ZHAO Yifei,GENG Xin,XU Lihu,OU Ting and ZHANG Ning.Considerations on the chemistry, manufacture and control requirements for conditional marketing authorization drugs in China[J].Journal of China Pharmaceutical University,2021,52(5):636-642. |
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| Authors: | ZHAO Yifei GENG Xin XU Lihu OU Ting and ZHANG Ning |
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| Affiliation: | Center for Drug Evaluation, National Medical Products Administration, Beijing 100022,China,Center for Drug Evaluation, National Medical Products Administration, Beijing 100022,China,Center for Drug Evaluation, National Medical Products Administration, Beijing 100022,China,Center for Drug Evaluation, National Medical Products Administration, Beijing 100022,China,Center for Drug Evaluation, National Medical Products Administration, Beijing 100022,China |
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| Abstract: | Drug Administration Law revised in 2019 proposed for the first time conditional marketing authorization at the legal level, marking the formal implementation of the conditional marketing authorization in China. This paper compares the regulations and technical requirements of conditional marketing authorization drugs in China with those in Europe and the United States, in an attempt to learn from the experience of chemistry, manufacture and control review of these drugs in Europe and the United States, and to discuss the pharmaceutical technical requirements of conditional marketing authorization drugs in China. |
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| Keywords: | chemical drugs conditional marketing authorization pharmacy technological requirements |
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