美國(guó)食品藥品管理局（FDA）于2015年12月發(fā)布了“多劑量、單劑量和單一患者用容器包裝的人用注射藥品的合適包裝類型術(shù)語(yǔ)的選擇和標(biāo)識(shí)建議行業(yè)指導(dǎo)原則（草案）”，該指導(dǎo)原則明確了人用注射藥品的包裝類型術(shù)語(yǔ)的定義，并對(duì)藥品說(shuō)明書和包裝標(biāo)簽上如何進(jìn)行標(biāo)識(shí)提供了相應(yīng)建議，以保證使用者很容易識(shí)別包裝類型，進(jìn)而保障用藥安全。我國(guó)目前尚無(wú)這類指導(dǎo)原則，介紹該指導(dǎo)原則的主要內(nèi)容，以期對(duì)我國(guó)制藥企業(yè)嚴(yán)謹(jǐn)而合理使用注射藥品的包裝類型術(shù)語(yǔ)和藥品監(jiān)管部門加強(qiáng)這方面的管理有所幫助。

FDA issued "Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use Guidance for Industry (Draft)" in October 2015. The guidance provides definitions for single-dose and multiple-dose containers, and introduces the definition of a new package type term, "single-patient-use" container. Furthermore, the guidance gives recommendation that how the appropriate package type term appears on the labeling of injectable medical products for human use so the user will be able to easily identify the package type, which can assure safety use. However, there is no similar guidance in China at present. This article introduces the main content of the guidance, hoping helpful for appropriately using these package type terms for industry and enhancing the management for agency of China.