美国食品药品监督管理局（FDA）于2020年7月发布了"妊娠、哺乳期和生殖潜能：人用处方药和生物制品说明书——内容和格式供企业用指导原则（第1次修订版）"。该指导原则详细介绍了说明书妊娠、哺乳期和生殖潜能3个小项的撰写内容和格式的要求。其中特别值得关注的是新增加了生殖潜能小项和重申废除妊娠字母分类法，而用叙述性风险摘要替代。详细介绍该指导原则，期望对中国修订相关法规和创建类似指导原则有益，对说明书"孕妇和哺乳期妇女用药"项目的撰写和监管也有帮助。

FDA issued the Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry (revision 1) in July 2020. The guidance introduced in detail the content and format requirements of the three sections of pregnancy, lactation and reproductive potential. In particular, the new reproductive potential subsection were added and the pregnancy letter categories were repealed and replaced by the narrative risk summary. It is expected to be helpful for the revision of relevant laws and regulations and the creation of similar guidelines in China, as well as for the writing and supervision of the use in pregnancy and lactation section in labeling.

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