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[摘要]
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。
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[Abstract]
In June 2015, FDA issued the guidance of "Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products——Content and Format for Industry (Small Entity Compliance Guide)", in order to help small entity comprehend and comply the guidance of "Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling"(PLLR) published on December 4, 2014. There is no related rule in China. This article introduced the main content of the former guidance including two sections of illustrations to PLLR as well as question and answer. The authors hope to improve the writing of pregnancy and lactation subsections in drug labeling in China.
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