藥品說明書的 [注意事項(xiàng)] 是消費(fèi)者用藥的重要參考，因此藥品生產(chǎn)企業(yè)認(rèn)真撰寫該項(xiàng)目對保障安全、有效地用藥非常重要。從2010年以來報送到國家食品藥品監(jiān)督管理總局藥品審評中心的藥品說明書樣稿中，收集不符合我國有關(guān)法規(guī)的 [注意事項(xiàng)] 71例，其中進(jìn)口藥36例、國產(chǎn)藥35例，涉及20多種臨床用藥類別，并分析存在的主要問題。結(jié)果發(fā)現(xiàn)不及時更新內(nèi)容是最多見而嚴(yán)重的問題，急待藥品生產(chǎn)廠商（包括進(jìn)口藥廠商）正確對待、及時改進(jìn)，以確保用藥安全。

Because the PRECAUTIONS section of drug labeling is the important reference for medication by consumer, therefore the drugs manufacturers should write the section seriously to ensure safe and effective medication. Seventy-one cases of the PRECAUTIONS section which does not accord with the regulations in China were collected from drug labeling drafts submitted for the registration to Center for Drug Evaluation under China Food and Drug Administration since 2010, including 35 cases of imported drugs and 36 cases of domestic drugs and more than 20 kinds of clinical drug categories, and the problems thereof are analyzed. Not to update the content in time is the most common and serious problems. The situation urgently needs to be reversed, correctly treated and timely improved by manufacturers, including imported drug manufacturers, in order to ensure the safe medication of users.