美國(guó)食品藥品管理局（FDA）于2017年8月發(fā)布了《藥品說(shuō)明中兒童安全包裝描述的指導(dǎo)原則》，主要介紹對(duì)藥品說(shuō)明書、紙盒標(biāo)識(shí)和容器標(biāo)簽中兒童安全包裝描述的要求。而目前在我國(guó)尚無(wú)類似的指導(dǎo)原則，詳細(xì)介紹該指導(dǎo)原則的主要內(nèi)容，期待引起藥品生產(chǎn)企業(yè)的重視與參考以及對(duì)我國(guó)藥監(jiān)部門有所啟示。

FDA issued the Child-Resistant Packaging Statements in Drug Product Labeling Guidance for Industry in August 2017, and mainly introduces the requirements for Child-Resistant Packaging Statements in Labeling, and on carton labeling and container labels. However, there is no similar guidance in our country. This paper introduces the guidance in detail, and expects to arise the attention and provide reference of pharmaceutical companies as well as the enlightenment to the administration of drug administration in China.