[关键词]
[摘要]
FDA为贯彻实施“妊娠和哺乳期规则(PLLR)”, 于2014年12月发布了供企业用的“人用处方药和生物制品说明书妊娠、哺乳期和生殖潜能的内容和形式”指导原则;而我国目前尚无相应的指导原则。介绍该指导原则的主要内容, 以期对我国处方药说明书涉及到这3个小项的撰写和监管有所帮助, 也对我国完善相应法规和创建相应指导原则有益。
[Key word]
[Abstract]
FDA issued "Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products—Content and Format Guidance for Industry" in order to implement the "pregnancy and lactation rules (PLLR)" in December 2014. This article introduces the main content. But there is no corresponding guidance in our country. It is expected to be helpful for writing and supervising the subsections of the labeling as well as to be benefit to the improvement of the relevant laws and create the relevant guidances in our country.
[中图分类号]
[基金项目]