药品说明书对药品检验机构确认标准的影响及建议  

Influence of Drug Instructions on the Confirmation Standards of Institute for Drug Control and Suggestions

作　　者：张丽丽 江志杰 李响 Zhang Lili;Jiang Zhijie;Li Xiang(Beijing Institute for Drug Control,Beijing 102206,China)

机构地区：[1]北京市药品检验研究院,北京102206

出　　处：《中国药事》2024年第3期257-260,共4页Chinese Pharmaceutical Affairs

摘　　要：目的:为进一步完善药品说明书审评和备案提出合理化的建议。方法:从药品检验机构确认检验标准的角度,通过分析药品检验机构依据药品说明书确定执行标准时遇到的问题,结合个人工作经验和思考。结果:部分药品说明书载明的【执行标准】项缺少标准修订的提示性文件、未及时进行修订及存在书写不规范的情况。结论:建议企业及时准确地更新药品说明书,同时药监部门在日常监督工作中加强药品说明书的动态管理。Objective:To put forward reasonable suggestions for further improving the review and filing of drug instructions.Methods:From the perspective of confirming the inspection standards by institute for drug control,the problems encountered by institute for drug control in determining the implementation standards according to the drug instructions were analyzed,combined with personal work experience and thinking.Results:The[executive standards]item specified in some drug instructions lacked the indicative documents for standard revision,was not revised in time,and had non-standard writing.Conclusion:It is suggested that enterprises should update the drug instructions timely and accurately,and the drug supervision department should strengthen the dynamic management of the drug instructions in the daily supervision work.

关 键 词：药品说明书 执行标准 修订 检验机构 工作建议 

分 类 号：R95[医药卫生—药学]