收集2012年審核的注冊(cè)報(bào)送的化學(xué)藥品說明書樣稿292例，分析其中存在的不符合我國(guó)法規(guī)要求的問題，對(duì)問題較多的醫(yī)學(xué)項(xiàng)目逐項(xiàng)詳細(xì)列舉其存在的主要問題和具體品種。結(jié)果發(fā)現(xiàn)樣稿普遍存在問題，很難找到一份完全符合法規(guī)要求的樣稿，問題較多的醫(yī)學(xué)項(xiàng)目包括警示語、藥理毒理、用法用量、不良反應(yīng)、藥代動(dòng)力學(xué)、注意事項(xiàng)和藥物過量等。這種現(xiàn)狀應(yīng)引起說明書撰寫者足夠重視。注意提高藥品說明書質(zhì)量，保證終端用戶安全有效用藥。

This paper collected 292 cases of chemical drug labeling drafts submitted for the registration and audited in 2012, and analyzed the problems thereof not meeting the requirements of laws and regulations of China. There are problems universally in the drug labeling drafts and it is very difficult to find one to conform to the laws and regulations request completely. More problems of medicinal sections include warning, pharmacology and toxicology, dosage and administration, adverse reactions, pharmacokinetics, and overdosage. This situation should arouse the enough attention of drafters for drug labeling. Pay attention to improve the specification of drug labeling and to ensure the safe and effective medication of the end users.