加入PIC/S与推进我国药品监管国际化的思考

Joining PIC/S and Thinking on Promoting the Internationalization of China's Drug Regulation

目的:回顾和分析了全球药品监管合作实践及我国药品监管的国际化历程,为我国尽早加入药品检查合作计划(PIC/S)从而实现GMP检查互信提出建议。方法:根据PIC/S对申请机构的要求,为迎接PIC/S对我国检查机构的评估做好准备,本文结合文献综述、检查现状分析和PIC/S审计清单指标解读,分析我国药品检查体系目前存在的差距。结果与结论:加入PIC/S有助加强各国监管机构间的合作和实现GMP检查互信,进一步推进我国药品监管的国际化进程。为顺利通过PIC/S对我国药品检查机构的正式评估、尽早成为PIC/S成员机构,我国应尽快在GMP标准提高、检查流程优化、检查员能力提升、检查机构质量体系建设等方面开展对标工作。

Objective:This paper reviews and analyzes the practice of global drug regulatory cooperation and the internationalization process of drug regulation in China,and makes suggestions for China to join the Pharmaceutical Inspection Co-operation Scheme(PIC/S)as soon as possible to achieve mutual recognition in GMP inspection.Methods:According to the requirements of PIC/S for applicant authorities,in order to prepare for the evaluation of China's drug inspection authorities by PIC/S,this paper analyzes the current gaps in China's drug inspection system based on literature review,inspection status analysis and interpretation of PIC/S audit checklist indicators.Results and Conclusion:Joining PIC/S will help strengthen cooperation between regulatory authorities in various countries and achieve mutual recognition in GMP inspection,and further promote the internationalization of drug regulation in China.In order to successfully pass the formal evaluation of China's drug inspection authorities by PIC/S and become a member authority of PIC/S as soon as possible,China should carry out benchmarking work as early as possible in terms of improving GMP standards,optimizing inspection processes,improving inspector capabilities,and building quality systems for inspection authorities.