美國食品藥品管理局（FDA）于2019年07月發(fā)布了"人用處方藥和生物制品說明書的藥物濫用和依賴項目——內(nèi)容和格式供企業(yè)用指導(dǎo)原則"（草案）。該指導(dǎo)原則介紹了撰寫藥物濫用和藥物依賴項=目的一般原則以及對其中管制物質(zhì)、濫用和依賴性3個小項的撰寫要求。而我國目前尚無類似指導(dǎo)原則，詳細(xì)介紹該指導(dǎo)原則，期望對我國說明書這部分內(nèi)容的撰寫和監(jiān)管有幫助。

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.