基于模糊综合评价法的复方中成药欧盟简化注册研究
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摘要
目的:通过欧盟药品注册法规及标准的研究,建立复方中成药欧盟简化注册评价指标体系及模糊综合评价模型,以期为复方中成药欧盟简化注册品种选择提供参考。方法:运用Delphi专家咨询法构建复方中成药欧盟简化注册评价指标体系,运用模糊综合评价法构建了模糊综合评价模型。结果:得到2个一级指标、3个二级指标、18个三级指标以及各指标权重,构建了模糊综合评价模型。对A企业113个复方中成药品种评价后,有61个品种不适宜进行欧盟简化注册。结论:运用模糊综合评价法构建的评价指标体系及综合评价模型,能够有效的运用于对注册品种的评价,对复方中成药欧盟简化注册具有参考意义。
Objective: Based on the study of EU drug registration regulations and standards,to establish the evaluation index system of the EU simplified registration of compound Chinese patent medicine and the fuzzy comprehensive evaluation model,aiming to provide references for the variety choice of the EU simplified registration of compound Chinese patent medicine. Methods: Delphi expert consultation method was applied to establish the evaluation index system of the EU simplified registration of compound Chinese patent medicine,and the fuzzy comprehensive evaluation method was used to establish the fuzzy comprehensive evaluation model. Results: A total of 2 first grade indexes,3 second grade indexes,18 third grade indexes and their weights were obtained. After evaluating 113 varieties of the compound Chinese patent medicine in enterprise A,61 varieties are not suitable for the EU simplified registration. Conclusion: The evaluation index system and the fuzzy comprehensive evaluation model established by the fuzzy comprehensive evaluation method can be effectively used in the evaluation of registered varieties,and have reference significance in the EU simplified registration of compound Chinese patent medicine.
Objective: Based on the study of EU drug registration regulations and standards,to establish the evaluation index system of the EU simplified registration of compound Chinese patent medicine and the fuzzy comprehensive evaluation model,aiming to provide references for the variety choice of the EU simplified registration of compound Chinese patent medicine. Methods: Delphi expert consultation method was applied to establish the evaluation index system of the EU simplified registration of compound Chinese patent medicine,and the fuzzy comprehensive evaluation method was used to establish the fuzzy comprehensive evaluation model. Results: A total of 2 first grade indexes,3 second grade indexes,18 third grade indexes and their weights were obtained. After evaluating 113 varieties of the compound Chinese patent medicine in enterprise A,61 varieties are not suitable for the EU simplified registration. Conclusion: The evaluation index system and the fuzzy comprehensive evaluation model established by the fuzzy comprehensive evaluation method can be effectively used in the evaluation of registered varieties,and have reference significance in the EU simplified registration of compound Chinese patent medicine.
引文
[1]张立群.中成药进入欧盟市场的途径和展望[A].山东中医药大学海外校友会.山东中医药大学海外校友会第二届学术研讨会论文集[C].山东中医药大学海外校友会:山东针灸学会,2018:6.
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[4]杨忠奇.板蓝根在英国获批带来哪些启示[N].健康报,2017-08-23(005).
[5]EC.Directive 2001/83/EC[EB/OL].2001-11-06.
[6]EC.Directive 2004/24/EC[EB/OL].2004-03-31.
[7]国家食品药品监督管理局药品认证管理中心.国外药品检查资料汇编:欧盟药品GMP指南[M].北京:中国医药科技出版社,2008,4:37-63.
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[2]中国科技信息编缉部印.地奥心血康获准欧盟药品注册上市[J].中国科技信息,2012,24(9):14.
[3]天士力控股集团.丹参胶囊成功获得欧盟植物药品注册批件[EB/OL].2017,6,28.
[4]杨忠奇.板蓝根在英国获批带来哪些启示[N].健康报,2017-08-23(005).
[5]EC.Directive 2001/83/EC[EB/OL].2001-11-06.
[6]EC.Directive 2004/24/EC[EB/OL].2004-03-31.
[7]国家食品药品监督管理局药品认证管理中心.国外药品检查资料汇编:欧盟药品GMP指南[M].北京:中国医药科技出版社,2008,4:37-63.
[8]世界卫生组织.药用植物种植和采集的生产质量管理规范(GACP)指南[J].现代中药研究与实践,2005,19(1-2),3-8,3-7.