FDA对药品说明书的药物滥用和依赖项目的撰写要求

FDA Requirements for drug abuse and dependence section in drug labling

美国食品药品管理局(FDA)于2019年07月发布了“人用处方药和生物制品说明书的药物滥用和依赖项目--内容和格式供企业用指导原则”(草案).该指导原则介绍了撰写药物滥用和药物依赖项目的一般原则以及对其中管制物质、滥用和依赖性3个小项的撰写要求.而我国目前尚无类似指导原则,详细介绍该指导原则,期望对我国说明书这部分内容的撰写和监管有帮助.

The FDA issued the Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products-Content and Format Guidance forIndustry(Draft)in July 2019.The guidance described the general principles for writing drug abuse and dependence section as well as the requirements for the three subsections of controlled substance,abuse and dependence.At present,there is no similar guidance in our country.This paper introduces the guidance in detail.It is hoped that it will be helpful to the writing and supervision of this part of the labeling in our country.