中国药物评价2024，Vol.41Issue(2)：172-176,5.
PIC/S技术标准指南体系分析
The Analysis on PIC/S Technical Standards and Guidelines System
颜若曦1
作者信息
- 1. 国家药品监督管理局食品药品审核查验中心,北京 100076
- 折叠
摘要
Abstract
The National Medical Products Administration(NMPA)submitted application to the Pharmaceutical Inspection Cooperation Program(PIC/S)officially in September 2023 and has become an official applicant.Nowadays,PIC/S published a large number of tech-nical standards and guidelines for pharmaceutical regulatory agencies and industry.It would be helpful to drug regulatory agencies and the pharmaceutical industry become more effective to promote and respond to the application by familiarity and mastery these technical stand-ards and guidelines.The study analyzes these technical standards and guidelines published by PIC/S according to the classification of GMP guides,inspectorates guidelines,guidance documents,aide-memoires and other documents.Based on the research on system level,it provides a reference for relevant units and individuals have a better understanding of PIC/S standard and guidance system.关键词
药品检查/药品检查合作计划/药品生产质量管理规范Key words
Drug inspection/Pharmaceutical Inspection Cooperation Program(PIC/S)/Good Manufacturing Practice(GMP)分类
医药卫生引用本文复制引用
颜若曦..PIC/S技术标准指南体系分析[J].中国药物评价,2024,41(2):172-176,5.
