[1]王圣鸣,田 侃,文 庆,等.中国第一批鼓励仿制药品目录的纳入品种分析[J].卫生经济研究,2020,(07):26-30.
 WANG Sheng-ming,TIAN Kan,WEN Qing,et al.Analysis of the First Encouraged Generic Drugs Catalogue in China[J].Journal Press of Health Economics Research,2020,(07):26-30.
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中国第一批鼓励仿制药品目录的纳入品种分析
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卫生经济研究[ISSN:1004-7778/CN:33-1056/F]

卷:
期数:
2020年07期
页码:
26-30
栏目:
药械管理
出版日期:
2020-06-30

文章信息/Info

Title:
Analysis of the First Encouraged Generic Drugs Catalogue in China
作者:
王圣鸣1田 侃1文 庆1陆 超1
1.南京中医药大学卫生经济管理学院, 江苏 南京 210000
Author(s):
WANG Sheng-mingTIAN KanWEN QingLU Chao
School of Health Economics and Management,Nanjing University of Chinese Medicine,Nanjing Jiangsu 210000,China
关键词:
鼓励仿制药品目录专利药用药可及性
Keywords:
encourage generic drug cataloguepatent medicinedrug accessibility
分类号:
R195
文献标志码:
A
摘要:
检索并整理《关于印发第一批鼓励仿制药品目录的通知》中所有品种的专利、纳入医保目录、同通用名下国产药品批文数、适应症等相关情况,探究纳入第一批鼓励仿制药品目录的药品特点,梳理我国鼓励仿制药品目录清单政策的发展,认为利匹韦林被排出的主要原因在于核心专利问题,预计此后的第二批、第三批鼓励仿制药品目录将会纳入更多专利有效期超过2年的药品;同时,随着我国专利链接制度的完善,鼓励仿制药品目录纳入品种的重点将更多集中在鼓励仿制且实际供应短缺的药品。
Abstract:
Search and sort out information of all drugs types from the“Notice on Issuing the First Encouraged Generic Drugs Catalogue”,including relevant patents,included in the medical insurance catalogue,numbers of domestic drug approvals under the common name,indications, and so on.Explore the drug characteristics included in the first encouraged generic drugs catalogue,and sort out the development of China's policies to encourage generic drugs catalogue,and believe that the main reason for remove ribavirin is the core patent problem. It is expected that the second and third catalogues of encouraged generic drug will include more drugs with patents valid for more than 2 years. At the same time,with the improvement of China's patent link system,the encouraging generic drug catalogue will focus more on encourage generics drugs which are in short supply.

参考文献/References:

[1] 中药品种保护条例[EB/OL].(1992-10-14)[2019-10-19]. http://www.nhc.gov.cn/fzs/s3576/201808/8ad11ae7578441589e7cea5be ecdcb94.shtml.
[2] 中共中央办公厅 国务院办公厅印发《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》[EB/OL].(2017-10-08)[2019-10-19].http://www.gov.cn/zhengce/2017-10/08/content_5230 105.htm.
[3] 国务院办公厅印发《关于改革完善仿制药供应保障及使用政策的意见》[EB/OL].(2018-04-03)[2019-10-19].http://www.gov.cn/xinwen/2018-04/03/content_5279580.htm.
[4] 关于印发加快落实仿制药供应保障及使用政策工作方案的通知[EB/OL].(2018-12-29)[2019-10-19].http://www.nhc.gov.cn/tigs/s7848/201812/8311038726604686a9e91832c81584b4.shtml.
[5] 国务院办公厅关于印发深化医药卫生体制改革2018年下半年重点工作任务的通知[EB/OL].(2018-08-28)[2019-10-19].http://www.nhc.gov.cn/tigs/s7848/201808/d76ed65240334deb8e 107be0f39bb3e7.shtml.
[6] 国务院办公厅关于印发深化医药卫生体制改革2019年重点工作任务的通知[EB/OL].(2019-06-04)[2019-10-19].http://www.nhc.gov.cn/tigs/s7848/201906/eb1d9f7a768446798dcffd244 09ada5c.shtml.
[7] 关于第一批鼓励仿制药品目录建议清单的公示[EB/OL].(2019-06-20)[2019-10-19].http://www.nhc.gov.cn/yaozs/s3582/201906/d99d60018330424895a6e0a8112d9034.shtml.
[8] 关于印发第一批鼓励仿制药品目录的通知[EB/OL].(2019-10-09)[2019-10-19].http://www.nhc.gov.cn/yaozs/s7656/201910/38e3961482c04b59a2aa3e36106b1a4f.shtml.
[9] 陈家宏,杨思佳.我国“Bolar例外”条款困境与出路分析[J].中国发明与专利,2018,15(10):62-68.
[10] 谈在祥,范舜.药品“4+7”带量集中采购背景下医药企业的挑战与应对[J].卫生经济研究,2019(8):13-15,19.

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更新日期/Last Update: 2020-06-30