為幫助小企業(yè)更好地理解和遵守"妊娠和哺乳期說(shuō)明書規(guī)則"(PLLR),FDA于2015年6月發(fā)布了"妊娠、哺乳期和生殖潛能:人用藥品和生物制品說(shuō)明書中項(xiàng)目的內(nèi)容和格式(小企業(yè)依從性指南)"指導(dǎo)原則。我國(guó)目前尚無(wú)相應(yīng)規(guī)范。本文介紹FDA該指導(dǎo)原則的主要內(nèi)容,包括對(duì)PLLR要求的說(shuō)明和問(wèn)答兩節(jié),期望對(duì)改進(jìn)我國(guó)藥品說(shuō)明書[孕婦及哺乳期婦女用藥]項(xiàng)的撰寫有所啟迪。

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.