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4 结论 OL]. (2018-05-23)[2020-12-22]. https://www.nmpa.gov.
近年来,特别是在 2018 年 5 月国家发布了《第一批 cn/zhuanti/ypqxgg/ggzhcfg/20180523110601517.html.
罕见病目录》以及一系列促进政策之后,我国罕见病药 [ 7 ] 中共中央办公厅,国务院办公厅 . 关于深化审评审批制
物上市数量不断增长,但是还远不能满足我国罕见病患 度改革鼓励药品医疗器械创新的意见[EB /OL]. (2017-
10-08)[2020-12-22]. http://www. gov. cn/zhengce/2017-
者的临床需求,并且上市的国产罕见病药物还非常缺
10/08/content_5230105.htm.
乏。因此,还需进一步加快国外已有罕见病药物的进
General Office of the CPC Central Committee,General
口,鼓励国内企业仿制高质量罕见病药物,加快罕见病
Office of the State Council. Opinions on deepening the re‐
新药的研发速度,扩大罕见病目录,让我国罕见病患者
form of the review and approval system and encouraging
有更多的治疗选择,使我国医药创新研发水平更上一 innovation of pharmaceutical and medical devices[EB/
层楼。 OL].(2017-10-08)[2020-12-22]. http://www.gov.cn/
参考文献 zhengce/2017-10/08/content_5230105.htm.
[ 1 ] 王雪,赵聪,许淑红,等. 我国罕见病用药可及性现状分 [ 8 ] 周盛明,李嘉瑶,周静,等. 中国罕见病用药可负担性评
析[J]. 中国临床药理学杂志,2021,37(8):1026-1032. 价[J]. 中国药业,2021,30(1):9-15.
WANG X,ZHAO C,XU S H,et al. Analysis of the rare ZHOU S M,LI J Y,ZHOU J,et al. Evaluation of the af‐
disease drugs availability in China[J]. Chin J Clin Pharma‐ fordability of orphan medical products in China[J]. China
col,2021,37(8):1026-1032. Pharm,2021,30(1):9-15.
[ 2 ] 刘鑫,李建涛,张鹏霄,等. 中国罕见病药物现状及与国 [ 9 ] 朱楚玉,孙维阳,常峰,等. 我国罕见病药品价格水平和
外对比分析研究[J]. 中国药学杂志,2019,54(10): 可负担性研究[J]. 中国药房,2021,32(8):897-903.
839-846. ZHU C Y,SUN W Y,CHANG F,et al. Study on the price
LIU X,LI J T,ZHANG P X,et al. Current status of and affordability of rare disease drugs in China[J]. China
orphan drugs in China and comparative analysis with Pharm,2021,32(8):897-903.
foreign countries[J]. Chin Pharm J,2019,54(10): [10] 俞颖慧,杨树俊,周斌. 我国罕见病药物优先审评审批情
839-846. 况简析[J]. 中国医药工业杂志,2023,54(2):277-282.
[ 3 ] 国家卫生健康委员会医政医管局.关于公布第一批罕见 YU Y H,YANG S J,ZHOU B. Brief analysis of priority
病 目 录 的 通 知 [EB/OL].(2018-05-11)[2019-12-30]. review of rare disease drugs in China[J]. Chin J Pharm,
http://www.gov.cn/xxgk/pages/viewdocument.jsp?dispatch- 2023,54(2):277-282.
Date=&staticUrl=/yzygj/s7659/201806/. [11] 王敏,范平安,王志远,等. 美国罕见病药物资格认定及
Medical Administration Bureau of the National Health 批准上市情况分析[J]. 中国药事,2021,35(12):1406-
Commission. Notice on the publication of the first list of 1413.
rare diseases[EB/OL]. (2018-05-11)[2019-12-30]. http:// WANG M,FAN P A,WANG Z Y,et al. Analysis of or‐
www. gov. cn/xxgk/pages/viewdocument. jspdispatchDate= phan drug designation and marketing approval in the
&staticUrl=/yzygj/s7659/201806/. United States[J]. Chin Pharm Aff,2021,35(12):1406-
[ 4 ] 吴诗瑜,张勘. 中国建立罕见病研究和防治策略的机遇 1413.
与未来挑战[J]. 上海医药,2011,32(10):502-504. [12] 刘清扬,刘鑫,王少红,等. 基于《第一批罕见病目录》的
WU S Y,ZHANG K. Opportunities and future challenges 罕见病药物可及性研究[J/OL]. 协和医学杂志,2023:1-
of establishing research and prevention strategies for rare 10[2023-08-23]. https://kns.cnki.net/kcms/detail/11.5882.
diseases in China[J]. Shanghai Med Pharm J,2011,32 R.20230823.1447.002.html.
(10):502-504. LIU Q Y,LIU X,WANG S H,et al. Research of accessi‐
[ 5 ] 邵文斌,李杨阳,王菲,等. 中国罕见病药品可及性现状 bility of rare disease drugs based on The First Rare Di-
及解决建议[J]. 中国食品药品监管,2019(2):8-15. sease Catalogue[J/OL]. Med J Peking Union Med Coll
SHAO W B,LI Y Y,WANG F,et al. Current situation Hosp,2023:1-10[2023-08-23]. https://kns.cnki.net/kcms/
and solutions of drug accessibility for rare diseases in detail/11.5882.R.20230823.1447.002.html.
China[J]. China Food Drug Adm Mag,2019(2):8-15. [13] 李亚茹,丁红,苏霞 . 罕见病药物研究现状分析与展望
[ 6 ] 国家药品监督管理局,国家卫生健康委员会 . 关于优化 [J]. 国际药学研究杂志,2017,44(2):107-111.
药品注册审评审批有关事宜的公告[EB/OL].(2018-05- LI Y R,DING H,SU X. Analysis and prospect of status of
23)[2020-12-22]. https://www.nmpa.gov.cn/zhuanti/ orphan drug research[J]. J Int Pharm Res,2017,44(2):
ypqxgg/ggzhcfg/20180523110601517.html. 107-111.
National Medical Products Administration, National (收稿日期:2023-11-02 修回日期:2024-03-25)
Health Commission. Announcement on optimizing mat‐ (编辑:刘明伟)
ters related to drug registration review and approval[EB/
中国药房 2024年第35卷第11期 China Pharmacy 2024 Vol. 35 No. 11 · 1295 ·