美國食品藥品管理局（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語的選擇和標識建議行業(yè)指導原則（草案）”，該指導原則明確了人用注射藥品的包裝類型術語的定義，并對藥品說明書和包裝標簽上如何進行標識提供了相應建議，以保證使用者很容易識別包裝類型，進而保障用藥安全。我國目前尚無這類指導原則，介紹該指導原則的主要內容，以期對我國制藥企業(yè)嚴謹而合理使用注射藥品的包裝類型術語和藥品監(jiān)管部門加強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.