美國食品藥品監(jiān)督管理局（FDA）于2022年9月發(fā)布了“人用OTC和處方藥品說明書中鈉、鉀和磷的定量信息供企業(yè)用的指導(dǎo)原則（草案）”。該指導(dǎo)原則草案要求人用處方藥和非處方藥說明書中要提供鈉、鉀和磷的定量信息，詳細(xì)闡明了對這些信息內(nèi)容和位置的建議并在附錄中列舉了示例。而中國目前還沒有類似的指導(dǎo)原則，詳細(xì)介紹FDA該指導(dǎo)原則草案的主要內(nèi)容，以期對我國這類說明書的撰寫和監(jiān)管有所幫助。

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 The draft guidance requires that quantitative information on sodium, potassium, and phosphorus shall be provided in the labeling for human prescription and over-the-counter,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 The draft guidance of FDA is introduced in detail, which is expected to be helpful to the writing and supervision of such labelings in China.

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