中国食品药品监管Issue(5)：114-121,8.DOI:10.3969/j.issn.1673-5390.2024.05.012
浅析国家药监局加入药品检查合作计划(PIC/S)中广东药监面临的形势与发展展望
Analysis of the Situation and Development Prospects of Guangdong Medical Products Administration Amidst the National Medical Products Administration's Accession to the Pharmaceutical Inspection Co-operation Scheme(PIC/S)
摘要
Abstract
The process of the National Medical Products Administration(NMPA)'s accession to the Pharmaceutical Inspection Co-operation Scheme(PIC/S)has reached the formal application stage,which will accelerate the internationalization and modernization of China's drug regulatory system.This paper briefly introduces the relevant situation of PIC/S,outlines the main process of NMPA's accession to PIC/S,and summarizes the progress of domestic GMP inspection system and related capability development in recent years.In this context,the Guangdong Medical Products Administration is expected to cooperate with Hong Kong and Macao to jointly promote the capacity building of drug regulation,accumulate practical experience,and contribute to the enhancement of national pharmaceutical regulation and industry.关键词
药品检查合作计划(PIC/S)/概况/加入进程/面临形势/发展展望Key words
Pharmaceutical Inspection Co-operation Scheme(PIC/S)/overview/accession process/facing situation/development prospects分类
医药卫生引用本文复制引用
马骏,洪建文,吴群悦,方维..浅析国家药监局加入药品检查合作计划(PIC/S)中广东药监面临的形势与发展展望[J].中国食品药品监管,2024,(5):114-121,8.基金项目
2022年度广东省药品检验所科研项目(SN2022002) （SN2022002）
