药品说明书规范研究

【作者】 谭睿；

【导师】 宋民宪；

【作者基本信息】 成都中医药大学 ， 中药学， 2012， 硕士

【摘要】 根据《药品管理法》明确规定,药品必须附有一份药品说明书。为了进一步规范管理药品说明书,于2006年3月15日国家食品药品监督管理局(SFDA)颁布了《药品说明书和标签管理规定》(局令24号令),要求上市药品说明书和标签都应当依照局令第24号的规定。然而,药品说明书存在诸多问题,由此而引发的警示缺陷也被越来越多的药品生产企业所重视。从卡马西平案例、温江桂枝茯苓丸案例等中也显现出药品说明书在侵权责任方面也有很多的争论。鉴于此,本论文尝试研究药品说明书规范。在本文中,除引言和结论外,共分为四章,主要内容如下：第一章查阅并统计了与药品说明书相关的现行法律法规,详细介绍我国现在药品说明书的管理模式。对现有法律和法规为基础,明确管理现状。第二章重点对351份药品说明书分析,统计并分析这些药品说明书中具体存在什么问题,查阅相关资料并做整理,得出存在三类问题：一般类错误分析、根本类错误分析、严重类错误分析,结合各有关法律法规进行理解。第三章药品说明书相关问题分析分别从行政角度和缺陷角度分析药品说明书的问题,对于存在的药品说明书应当公开而现在大部分没有公开、《药典》等相关标准本身不规范问题、并分析药品说明书充分性是有限的、药品说明书的可理解性有一定标准等。结合药品特点,深入分析和理解。第四章提出药品说明书的发展和完善,药品说明书应明确具体人群、药品生产企业应严格处理以及药品标准修订。更多还原

【Abstract】 According to the" Drug Administration Law" provisions, drugs must be accompanied by instructions. In order to standardize the management of the drugs manual and labels, in March15,2006the State Food and Drug Administration announced the" provisions on the administration of the drugs manual and labels"(Bureau No.24), requirement our country listed drugs manual and labels should be consistent with the Bureau order No.24. However, there exist a lot of problems of manual of medicines and chemical reagents, the resulting warning defects has been more and more valued by the drugs production enterprise. From carbamazepine case, Wenjiang Fuling pill case also showed the drug specifications in tort liability also has a lot of controversy. In view of this, this paper attempts to regulate aspects of drug instructions.In this paper, except the introduction and conclusion, is divided into four chapters, the main contents are as follows:The first chapter review and statistics with the drug instructions related to the current laws and regulations, introduced our country now drugs manual management mode. To the existing laws and regulations as the basis for drug instructions, clear management status.The second chapter focuses on the analysis of351drug instructions, statistics and analysis of these medicines in specific existing what problem, access to relevant information and do finishing, that the three kinds of problems:a general class of error analysis, the fundamental class of error analysis, serious error analysis. And for each of the relevant laws and regulations and understanding.The third chapter analysis of related problems of drug instructions from administrative angle and defect analysis of manual of medicines and chemical reagents, for the presence of drug instructions should be open but now most did not publicly," Pharmacopoeia" and other related standards non-standard problem such as well as drug specifications fully is limited, the drug instruction can understand a certain standard. To express. Combination drug characteristics, in-depth analysis and understanding.The fourth chapter proposed drug specifications developed and perfect, present drug instructions should be clear of manual of medicines and chemical reagents specific population, drug production enterprises should be strictly treated as well as for drug standard revision.更多还原