美國食品藥品監(jiān)督管理局（FDA）于2020年7月發(fā)布了"妊娠、哺乳期和生殖潛能：人用處方藥和生物制品說明書——內(nèi)容和格式供企業(yè)用指導(dǎo)原則（第1次修訂版）"。該指導(dǎo)原則詳細(xì)介紹了說明書妊娠、哺乳期和生殖潛能3個小項的撰寫內(nèi)容和格式的要求。其中特別值得關(guān)注的是新增加了生殖潛能小項和重申廢除妊娠字母分類法，而用敘述性風(fēng)險摘要替代。詳細(xì)介紹該指導(dǎo)原則，期望對中國修訂相關(guān)法規(guī)和創(chuàng)建類似指導(dǎo)原則有益，對說明書"孕婦和哺乳期婦女用藥"項目的撰寫和監(jiān)管也有幫助。

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 In particular, the new reproductive potential subsection were added and the pregnancy letter categories were repealed and replaced by the narrative risk summary.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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