• 中国核心期刊(遴选)数据库收录期刊
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中国药物评价 ›› 2022, Vol. 39 ›› Issue (4): 355-357.

• 药品管理 • 上一篇    下一篇

省级药检机构国内药品注册检验管理现状思考

李响, 张丽丽, 李宁*, 戴红   

  1. 北京市药品检验研究院, 北京 102206
  • 收稿日期:2022-05-20 修回日期:2022-07-26 出版日期:2022-08-28 发布日期:2022-10-08

Reflection on the Current Managerial Situation of Domestic DrugRegistration and Inspection in Provincial Drug Inspection Institutions

  1. Beijing Institute for Drug Control, Beijing 102206
  • Received:2022-05-20 Revised:2022-07-26 Online:2022-08-28 Published:2022-10-08

摘要: 新版《药品注册管理办法》已实施1年,各种配套注册法规文件逐步完善,省级药检机构的国内药品注册检验管理工作亦随之逐步调整。通过梳理省级药品检验机构承接国内药品注册检验任务的范畴、分类及来源,分析相关管理工作的主要变化,提出新版《药品注册管理办法》实施工作中需注意的情况,以期为相关管理工作的开展提供更加全面的思路。

关键词: font-size:medium, ">省级药检机构;国内药品;注册检验

Abstract: Since the implementation of the new version of "Drug Registration and Administration" last year, a variety of supporting registration regulations and documents have been gradually enhanced, following the registration and inspection of domestic drug management at the provincial level drug testing institutions. By classifying the scope, classification, and sources of the provincial drug testing organizations tasked with domestic drug registration testing, and analyzing the major changes in the management of the relevant work, the new version of "Drug Registration and Administration" will pay more attention to the implementation of the situation, so as to provide more comprehensive ideas for the development of management.

Key words: Provincial drug inspection institutions, Domestic drug, Registration inspection

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