首页|药品说明书对药品检验机构确认标准的影响及建议

药品说明书对药品检验机构确认标准的影响及建议

扫码查看
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.
Influence of Drug Instructions on the Confirmation Standards of Institute for Drug Control and Suggestions
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.

drug instructionsexecutive standardsrevisioninstitute for drug controlwork suggestions

张丽丽、江志杰、李响

展开 >

北京市药品检验研究院,北京 102206

药品说明书 执行标准 修订 检验机构 工作建议

2024

中国药事
中国食品药品检定研究院(中国药品生物制品检定所)

中国药事

CSTPCD
影响因子:0.844
ISSN:1002-7777
年,卷(期):2024.38(3)
  • 16