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中日中药复方制剂药品说明书在告知义务上的差异性
引用本文:王言.中日中药复方制剂药品说明书在告知义务上的差异性[J].亚太传统医药,2008,4(2):92-94.
作者姓名:王言
作者单位:中国药科大学中药学院,江苏,南京,210009
摘    要:目的:找出我国中药制剂企业在药品说明书上存在的缺陷,并且通过和先进国家的比较,提出改进手段。方法:采用文献研究方法和比较研究方法,研究中日两国中药复方制剂药品说明书以及相关法律。结论:我国中药制药企业应该加紧对药品说明书进行修订,加强抵御风险能力。

关 键 词:告知义务  说明书  中国中药制剂  日本汉方制剂  不良反应

Differences in Inform Obligations of Instructions of Chinese Medicine Compound Preparation Between China and Japan
Wang Yan.Differences in Inform Obligations of Instructions of Chinese Medicine Compound Preparation Between China and Japan[J].Asia-Pacific Traditional Medicine,2008,4(2):92-94.
Authors:Wang Yan
Institution:Wang Yan (China Pharmaceutical College of Traditional Chinese Medicine, Nanjing 210009, China)
Abstract:Objective: To identify our pharmaceutical enterprises in the Chinese medicine preparations on the statement of deficiencies exist, and through the relatively advanced countries and proposed improvement measures. Methods: A literature research methods and research methods comparison study the statement of Chinese and Japanese pharmaceutical compound preparation, as well as relevant laws. Conclusion: Our Chinese pharmaceutical enterprises should accelerate the revised statement of drugs, strengthening withstand risks.
Keywords:Obligation  Instruction  Chinese medicine preparations  Adverse reactions
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