萧惠来.71例药品说明书样稿中 [注意事项] 问题分析[J].药物评价研究,2014,37():
71例药品说明书样稿中 [注意事项] 问题分析
Analysis of problem on 71 cases of drug labeling [precaution] drafts
  
DOI:
中文关键词:  药品说明书;注意事项;用药安全;内容更新
英文关键词:drug labeling; precaution; safe medication; updating content
基金项目:
作者单位
萧惠来 国家食品药品监督管理总局药品审评中心,北京 100038 
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中文摘要:
      药品说明书的 [注意事项] 是消费者用药的重要参考,因此药品生产企业认真撰写该项目对保障安全、有效地用药非常重要。从2010年以来报送到国家食品药品监督管理总局药品审评中心的药品说明书样稿中,收集不符合我国有关法规的 [注意事项] 71例,其中进口药36例、国产药35例,涉及20多种临床用药类别,并分析存在的主要问题。结果发现不及时更新内容是最多见而严重的问题,急待药品生产厂商(包括进口药厂商)正确对待、及时改进,以确保用药安全。
英文摘要:
      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.
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