介紹我國(guó)國(guó)家食品藥品監(jiān)督管理總局、美國(guó)食品藥品管理局和歐洲藥品局對(duì)處方藥說(shuō)明書中[適應(yīng)癥]項(xiàng)目撰寫要點(diǎn)的要求.并以這些要求和其他有效而安全用藥要求作為尺度,分6個(gè)方面分析了在我國(guó)提交藥品注冊(cè)申請(qǐng)時(shí)報(bào)送的61例的不符合上述要求的說(shuō)明書樣稿,結(jié)合11個(gè)典型實(shí)例概述了目前存在的主要問(wèn)題,包括進(jìn)口藥和跨國(guó)公司在華藥廠的藥品說(shuō)明書樣稿,指出不符合以上要求以及違背有效且安全用藥基本原則的現(xiàn)象,有助于藥品說(shuō)明書的規(guī)范撰寫和保障安全用藥.

The writing highlights of indication section of labeling for prescription medicine required by CFDA, FDA, and EMA are described. Based on the above requirements as well as other demands related to effective- and safe-using drugs, the paper analyzes the typical cases of labeling drafts submitted for registration in our country from six aspects, discussing with the eleven typical representatives to overview the current problems, including the labeling drafts of import medicine and multi-national corporation, in order to reveal the manifestations that do not meet these requirements and against the basic principles for effective and safe medication. It is expected to be helpful to write the normal labeling of drugs and ensure safe medication in China.