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)

国家药监局加入药品检查合作计划(PIC/S)的进程已经进入正式申请阶段,这将加速推动我国药品监管体系国际化现代化发展。本文简要介绍了PIC/S的相关情况,梳理了国家药监局加入该组织的主要进程以及国内近年来在药品GMP检查体系和相关能力建设方面的工作进展,展望了该形势下广东省药监局联合港澳地区协同推进药品监管能力建设、凝聚自身实践经验、助力国家药品监管和药品产业发展的工作脉络。

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.