FDA為貫徹實施“妊娠和哺乳期規(guī)則(PLLR)”, 于2014年12月發(fā)布了供企業(yè)用的“人用處方藥和生物制品說明書妊娠、哺乳期和生殖潛能的內容和形式”指導原則;而我國目前尚無相應的指導原則。介紹該指導原則的主要內容, 以期對我國處方藥說明書涉及到這3個小項的撰寫和監(jiān)管有所幫助, 也對我國完善相應法規(guī)和創(chuàng)建相應指導原則有益。

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.