Suggestions for Promoting China’s Drug Regulatory Agency to Join Pharmaceutical Inspection Co-operation Scheme-PIC/S  

作　　者：Hu Shigao Wu Zhiang 

机构地区：[1]School of Business Administration,Shenyang Pharmaceutical University,Shenyang 110016,China [2]Anhui Center for Drug Evaluation and Inspection,Hefei 230051,China [3]Yeehong Business School,Shenyang Pharmaceutical University,Beijing 10055,China

出　　处：《Asian Journal of Social Pharmacy》2023年第3期206-212,共7页亚洲社会药学（英文）

摘　　要：Objective To identify and reduce the gap between China’s drug GMP inspection and pharmaceutical inspection co-operation scheme(PIC/S)audit checklist,find out the key improvement items,and revise them pertinently,which will promote the process of China joining PIC/S.Methods The general situation of PIC/S organization and audit checklist were introduced first,and then the accession of several countries that joined the organization was analyzed.Meanwhile,the process of China’s participation in PIC/S was sorted out.After referring to the contents of PIC/S audit checklist,the problems of GMP inspection system in China were studied.Results and Conclusion There are still many problems in GMP inspection in China.Some suggestions are put forward for improvement and change,which can provide reference for the development of drug inspection agencies at all levels in China.

关 键 词：GMP inspection pharmaceutical inspection co-operation scheme(PIC/S) audit checklist drug regulatory agency 

分 类 号：R95[医药卫生—药学]