FDA于2024年4月發(fā)布了“NDA和ANDA中組成說明的內容和格式以及說明書中相應成分說明的供企業(yè)用的指導原則草案”。該指導原則詳盡而又具體地介紹了藥學申報資料中藥物組成說明以及說明書中相應成分說明的最佳撰寫方法。列舉了常見問題并提出了避免這些問的建議。該指導原則末還給出了規(guī)范撰寫的示例，使之最佳撰寫方法一目了然。而我國目前還沒有類似的指導原則，詳細介紹FDA該指導原則，期待對我國藥物研究者這兩方面內容的規(guī)范撰寫有幫助，也對我國藥品監(jiān)管部門的相應審評有啟示。

FDA issued the Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in NDAs and ANDAs Draft Guidance for Industry in April 2024. This guidance provides a detailed and specific introduction to the best writing method for drug composition statements in pharmaceutical application materials and corresponding ingredient statements in labelings. Listed common problems and provided recommendations to avoid them. The guidance also provides examples of standardized writing at the end, making the best writing method clear at a glance. However, there is currently no similar guidance in China. This article provides a detailed introduction to the FDA's guidance, hoping to be helpful for the standardized writing of these two aspects for drug researchers in China, and also provide inspiration for the corresponding review of drug regulatory departments in China.

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