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为帮助小企业更好地理解和遵守“妊娠和哺乳期说明书规则”(PLLR),FDA于2015年6月发布了“妊娠、哺乳期和生殖潜能:人用药品和生物制品说明书中项目的内容和格式(小企业依从性指南)”指导原则。我国目前尚无相应规范。本文介绍FDA该指导原则的主要内容,包括对PLLR要求的说明和问答两节,期望对改进我国药品说明书[孕妇及哺乳期妇女用药]项的撰写有所启迪。
To help small businesses better understand and comply with the “Rules for Pregnancy and Lactation Instructions” (PLLR), the FDA released in June 2015 “Pregnancy, Lactating and Reproductive Potential: Instructions for use in human medicines and biologicals Project Content and Format (Small Business Compliance Guidelines) ”Guiding Principles. At present there is no corresponding standard in our country. This article describes the main contents of the FDA guidelines, including two sections on the requirements of PLLR and Q & A. We hope it will be helpful to improve the writing of the [Drugs for pregnant women and lactating women] in our country.