2013-2018年俄罗斯联邦抗癌药物进口替代分析结果

O. A. Ryzhova, T. L. Moroz
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引用次数: 2

摘要

的目标。鉴于抗癌药物的社会重要性,本研究的目的是对2013年和2018年列入《生命与基本药物目录》的国内外抗癌药物在进口替代方面的范围进行比较分析。材料和方法。该研究是通过比较2013年和2018年国家药品注册目录中列入生命和基本药物清单的注册抗癌制剂的数据进行的。采用Fisher z检验方法对数据进行统计处理。总的来说,2013年在俄罗斯联邦注册的抗癌药物商标共有286个。其中94架是俄罗斯制造的,占33%。2013年分析组国内生产的原料药有19种,占71种国际非专利名称的27%。2018年,共有71家国际注册机构注册了393个抗癌药物商品名。162种药物是俄罗斯制造的,占41%。2013 - 2018年,国产抗癌药物数量增长8%,呈现统计学上显著的正向趋势。为了增加抗癌药物生产中的进口替代量,有必要向首次注册国内类似物的俄罗斯制造商提供国家支持。应特别注意国内药品的生产,没有这些药品就不可能确保国家的药品安全。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
RESULTS OF IMPORT SUBSTITUTION ANALYSIS OF ANTI-CANCER MEDICATIONS IN THE RUSSIAN FEDERATION (2013–2018)
The aim. Due to the social importance of anticancer drugs, the aim of the study is to conduct a comparative analysis of the range of domestic and foreign anticancer medications included in the Lists of Vital and Essential Drugs in 2013 and 2018 in the aspect of import substitution.Materials and methods. The study was conducted by comparing the data on the registered anticancer preparations included in the list of Vital and Essential Drugs in the State Register of Medicines in 2013 and 2018. Statistical processing of the data was carried out on the basis of Fisher Z-test method.Results. All in all, there were 286 trade names of anticancer drugs registered in the Russian Federation in 2013. 94 of them, i.e. 33%, were Russian-made. In 2013, there were 19 pharmaceutical substances of domestic production in the analyzed group, which accounted for 27% of 71 INNs (International nonproprietary name). As for 71 INNs, in 2018 there were 393 registered trade names of anticancer drugs. 162 drugs, i.e. 41%, were Russian-made. From 2013 to 2018, a statistically significant positive trend of the increase in the number of domestic anticancer drugs by 8% was revealed.Conclusion. In order to increase the volume of import substitution in the production of anticancer drugs, it is necessary to provide state support to Russian manufacturers, who register domestic analogues for the first time. A particular attention should be paid to the production of domestic pharmaceutical substances, without which it is impossible to ensure the drug safety of the country.
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