美国食品药品管理局（FDA）于2015年12月发布了“多剂量、单剂量和单一患者用容器包装的人用注射药品的合适包装类型术语的选择和标识建议行业指导原则（草案）”，该指导原则明确了人用注射药品的包装类型术语的定义，并对药品说明书和包装标签上如何进行标识提供了相应建议，以保证使用者很容易识别包装类型，进而保障用药安全。我国目前尚无这类指导原则，介绍该指导原则的主要内容，以期对我国制药企业严谨而合理使用注射药品的包装类型术语和药品监管部门加强这方面的管理有所帮助。

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.