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药品说明书是载明药品信息的法定文件,对指导公众合理用药起着至关重要的作用。在欧美药品的申报体系和指南中,均要求申请者在药品上市前必须完成药品说明书可读性测试研究,以保证说明书内容通俗易懂,指导公众合理安全用药,避免用药不当可能导致的风险。由于审评理念和标准的差距,目前中国在新药评审的过程中缺乏药品说明书可读性测试研究的要求、法规和指南。以国内申报欧盟成功的品种丹参胶囊注册上市实践为案例,分析欧盟对于药品说明书可读性测试研究的要求,以期为我国建立和实施药品说明书可读性研究的管理思路提供借鉴和参考。
Drug instructions is a statutory document containing drug information, play a crucial role in guiding the public to rational drug use. In European and American drug reporting systems and guidelines, require applicants to be drug listed in the drug readability test must be completed before the study to ensure that the contents of the instructions easy to understand, guide the public reasonable and safe medication, to avoid the risk of improper medication may lead. Due to the gap between the concept of review and the standard, at present, China lacks the requirements, regulations and guidelines for the readability testing of drug specifications in the process of drug review. Taking the domestic successful practice of the registration and listing of Danshen capsule as a successful case in the EU, this paper analyzes the EU requirements on the readability test of drug specification, and hopes to provide reference and reference for our country to establish and implement the readability study of drug specification.