中国临床药理学杂志2024，Vol.40Issue(15)：2301-2304,4.DOI:10.13699/j.cnki.1001-6821.2024.15.032
PIC/S临床试验用药品附录及检查备忘录的初步探讨
Preliminary discussion on the appendix and inspection memorandum of investigational medicinal products of PIC/S
陆德 1胡敬峰 2许文艳 1裴宇盛 3叶笑4
作者信息
- 1. 国家药品监督管理局药品审评检查长三角分中心,上海 201203
- 2. 山东省食品药品审评查验中心,山东济南 250013
- 3. 中国食品药品检定研究院,北京 100050
- 4. 国家药品监督管理局食品药品审核查验中心,北京 100050
- 折叠
摘要
Abstract
The National Medical Products Administration have become an official applicant of the Pharmaceutical Inspection Co-operation Scheme(PIC/S)in 2023,and the good manufacturing practice appendix and inspection memorandum are key documents of PIC/S.Based on the analysis of the history,framework and main contents of the appendix and inspection memorandum of PIC/S investigational medicinal products,this paper discusses the key contents of the appendix and inspection memorandum of PIC/S clinical trial drugs,and provides reference for the inspection work.关键词
临床试验用药品/生产质量管理规范/药品检查/国际药品检查合作组织/检查备忘录Key words
investigational medicinal product/good manufacturing practice/Pharmaceutical Inspection Co-operation Scheme/drug inspection分类
医药卫生引用本文复制引用
陆德,胡敬峰,许文艳,裴宇盛,叶笑..PIC/S临床试验用药品附录及检查备忘录的初步探讨[J].中国临床药理学杂志,2024,40(15):2301-2304,4.
