美国食品药品监督管理局（FDA）于2022年9月发布了“人用OTC和处方药品说明书中钠、钾和磷的定量信息供企业用的指导原则（草案）”。该指导原则草案要求人用处方药和非处方药说明书中要提供钠、钾和磷的定量信息，详细阐明了对这些信息内容和位置的建议并在附录中列举了示例。而中国目前还没有类似的指导原则，详细介绍FDA该指导原则草案的主要内容，以期对我国这类说明书的撰写和监管有所帮助。

The U. S. Food and Drug Administration (FDA) published in September 2022: "Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products Guidance for Industry (Draft)". The draft guidance requires that quantitative information on sodium, potassium, and phosphorus shall be provided in the labeling for human prescription and over-the-counter, detailing recommendations for the content and placement of the information, and providing examples in the appendix. However, there is no similar guidance in our country. The draft guidance of FDA is introduced in detail, which is expected to be helpful to the writing and supervision of such labelings in China.

R951