国家药品补充检验方法管理工作的现状与思考

Current Situation of and Reflection on Administration on National Drug Inspection and Additional Testing Methods and Projects

目的总结分析当前国家药品补充检验方法和检验项目管理工作的现状和存在的问题,为进一步完善国家药品补充检验方法和检验项目的管理工作提供建议。方法查阅国内相关规定及文献,与实践、调研相结合,总结现状,分析问题,提出相应对策。结果与结论应建立药品补充检验方法管理办法及技术指导文件,修改审批流程,增加时限要求;对已发布的补充检验方法及时进行修订;建立动态更新的补充检验方法数据库,进一步加强对药品补充检验方法和检验项目的管理。

Objective To summarize and analyze the situation and problems of administration on National drug inspection and additional testing methods and projects, in order to provide advice for further improvement in the management of national drug inspection and additional testing methods and projects. Methods By searching the domestic regulations and literature, combined with practice and investigation, the current situation was summarized, the problems were analyzed, and corresponding countermeasures were proposed. Results and Conclusion Management practices and technical guidance document should be established for the additional testing methods, the approval process amended and the requirement of testing time limit added; the published methods in a timely manner amended; a database of the constantly updated additional testing methods and projects established, so as to further strengthen the management of national drug standards.