摘要
目的 药品的生产场所是为满足药品生产要求的一系列生产要素的组合,其既是药品生产的硬件条件,也是注册申报时审评的物质基础。笔者旨在初步探讨我国化学药品申报资料中生产线的内涵、外延,以期为规范药品注册申报提供一定的参考。方法 在梳理我国化学药品申报资料中关于生产场所信息的历次要求的基础上,结合日常药学审评工作以及具体案例进行分析。结果与结论 应明确申报资料中拟定生产线的内涵及边界,强化不同监管部门之间的有效沟通,及时更新相关证明性信息,同时还应持续关注我国关于生产线相关变更的法律法规修订进展。
Abstract
OBJECTIVE The manufacturing site of drugs is a combination of a series of production factors to meet the requirements of drugs production, which is not only the material basis of drugs production, but also the evaluation basis for the review when applying for registration. The purpose of this paper is to preliminarily discuss the definition and extension of production lines for chemical drugs in China, and provide some references for standardizing new drug application. METHODS The historical requirements for manufacturing site information in application materials of chemical drugs in China were briefly introduced, with daily pharmaceutical evaluation works and specific cases study. RESULTS AND CONCLUSION It should make clear the definition and extension of production lines in the application materials, strengthen the effective communication between different regulatory authorities, update the relevant information in time, and should pay continuing attention to the revision progress of the laws and regulations requirements on the production line in China.
关键词
化学药品 /
生产线 /
相关要求 /
药品审评
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Key words
chemical drug /
production line /
requirement /
drug assessment
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龚青, 田洁.
我国化学药品申报资料中关于生产线相关要求的审评考虑[J]. 中国药学杂志, 2020, 55(3): 239-244 https://doi.org/10.11669/cpj.2020.03.014
GONG Qing, TIAN Jie.
Reflections on the Requirements for Production Lines in Application of Chemical Drugs in China[J]. Chinese Pharmaceutical Journal, 2020, 55(3): 239-244 https://doi.org/10.11669/cpj.2020.03.014
中图分类号：
R917
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