美國(guó)食品藥品管理局（FDA）于2017年12月發(fā)布了"復(fù)方激素類避孕藥說(shuō)明書指導(dǎo)原則"。該指導(dǎo)原則對(duì)這類藥物說(shuō)明書各個(gè)項(xiàng)目提出了詳細(xì)而具體的要求。介紹該指導(dǎo)原則的主要內(nèi)容，期待對(duì)我國(guó)這類藥物說(shuō)明書充實(shí)內(nèi)容、補(bǔ)充重要信息和準(zhǔn)確反映目前的科學(xué)認(rèn)識(shí)水平有所幫助。

FDA issued the "Labeling for Combined Hormonal Contraceptives Guidance for Industry" in December 2017. The guidance includes detailed and specific requirements for each section of Combined Hormonal Contraceptives (CHCs) Labeling. This paper introduces the main contents of the guidance, and expects to be helpful to enrich the contents, supplement important information, and accurately reflect the current level of scientific understanding for the Labeling of CHCs in China.