FDA“NDA和ANDA中组成说明的内容和格式以及说明书中相应成分说明的供企业用的指导原则”介绍及启示  

Introduction and inspiration of FDA's Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in NDAs and ANDAs Draft Guidance for Industry

作　　者：萧惠来 XIAO Huilai(Center for Drug Evaluation,National Medical Products Administration,Beijing 100076,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100076

出　　处：《药物评价研究》2024年第10期2203-2209,共7页Drug Evaluation Research

摘　　要：FDA于2024年4月发布了“NDA和ANDA中组成说明的内容和格式以及说明书中相应成分说明的供企业用的指导原则草案”。该指导原则详尽而又具体地介绍了药学申报资料中药物组成说明以及说明书中相应成分说明的最佳撰写方法。列举了常见问题并提出了避免这些问的建议。该指导原则末还给出了规范撰写的示例,使之最佳撰写方法一目了然。而我国目前还没有类似的指导原则,详细介绍FDA该指导原则,期待对我国药物研究者这两方面内容的规范撰写有帮助,也对我国药品监管部门的相应审评有启示。FDA issued the Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in NDAs and ANDAs Draft Guidance for Industry in April 2024.This guidance provides a detailed and specific introduction to the best writing method for drug composition statements in pharmaceutical application materials and corresponding ingredient statements in labelings.Listed common problems and provided recommendations to avoid them.The guidance also provides examples of standardized writing at the end,making the best writing method clear at a glance.However,there is currently no similar guidance in China.This article provides a detailed introduction to the FDA's guidance,hoping to be helpful for the standardized writing of these two aspects for drug researchers in China,and also provide inspiration for the corresponding review of drug regulatory departments in China.

关 键 词：美国食品药品管理局(FDA) 新药申请和仿制药申请 组成说明 成分说明 说明书 指导原则 

分 类 号：R926[医药卫生—药学]