Citation: | DING Jinxi, LIU Weijing, LI Wei, LIU Yangyang, BAI Gengliang. Analysis of orphan drug accessibility and marketing authorization system in China[J]. Journal of China Pharmaceutical University, 2014, 45(1): 111-117. DOI: 10.11665/j.issn.1000-5048.20140121 |
[1] |
U.S.Food and Drug Administration(FDA).Rare diseases take spotlight in annual event[EB/OL].(2011-02-24)[2012-12-22].http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm244408.htm.
|
[2] |
Gong SW,Zhang M.Thinking on the definitions of rare disease and orphan drugs in China[J].Chin J New Drugs(中国新药杂志),2006(15):1 225-1 229.
|
[3] |
Tao Y.The current situation of orphan drug regulation in the United States[J].Chin Pharm J(中国药学杂志),2001,36(9):634-636.
|
[4] |
Jiang H.Review and reference on the USA drug market access system[J].Guangxi Soc Sci(广西社会科学),2013(2):89-93.
|
[5] |
Zhu JP.Exploration of ancient Chinese on the relation of geographical environment tohuman diseases[J].China J Tradit Chin Med Pharm(中华中医药杂志),2011,26(12):2 791-2 794.
|
[6] |
Xin ZJ,Wang ZS,Chen ZJ.Studying the status of orphan drugs in China and its countermeasures[J].Chin Health Serv Manage(中国卫生事业管理),2011(5):349-351.
|
[7] |
Li HT.Analys is on the accessibility of drugs in China[J].Chin Health Serv Manage(中国卫生事业管理),2009(9):612-614.
|
[8] |
Ding JX, Li XT, Zhao Y. The unify operation pattern of drug reimbursement list under the policy of new medical reform-based on the empirical analyses of the drug reimbursement list of new cooperative medical system[J].Chin Pharm Aff(中国药事),2011,25(10):962-968.
|
[9] |
Liu LQ.Research on strategies of essential medicines availability in community health service facilities(促进社区卫生服务机构基本药物可获得性策略研究)[D].Wuhan:Huazhong University of Science and Technology,2009.
|
[10] |
U.S.Food and drug administration.search orphan drug designations and approvals[EB/OL].(2012-12-02)[2013-01-03].http://www.accessdata.fda.gov/scripts/opdlisting/oopd/OOPD_Results_2.cfm.
|
[11] |
List of medicinal products for rare diseases in Europe [EB/OL].(2013-10-01)[2013-12-20].http://www.orpha.net/orphancome/cahriers/docs/GB/list_of_orphan_drugs_in_europe.pdf.
|
[12] |
Ministry of Health,Labour and Welfare.Rare disease medicine formulated product catalogue[EB/OL].[2008-09-05](2013-01-03).http://www.mhlw.go.jp/english/index.html.
|
[13] |
Korea food and drug administration[EB/OL].[2012-08-30](2012-12-29).http://www.mfds.go.kr/index.do.
|
[14] |
China Food and Drug Administration. State Food and Drug Administration issued ″special approval of new drug registration regulations″[EB/OL].[2009-01-09](2013-01-01).http://www.sda.gov.cn/WS01/CL0051/35168.html.
|
[15] |
Gao S.Do not let a rare disease ″rare″ drug[N].Health News(健康报),2010-06-19(5).
|
[16] |
Gong SW. Management strategies of improving orphan drugs access in China(促进我国罕见病患者药品可及性的管理策略研究)[D].Wuhan:Huazhong University of Science and Technology,2008.
|
[17] |
Sun GJ.Discussion about market concentration ratio of pharmaceutical industry in China[J].Chin Pharm(中国药房),2004,15(4):588-590.
|
[18] |
Rare Disease Relief Public Fund.China rare disease network[EB/OL].(2010-01-01)[2012-12-26].http://www.chinararedisease.cn/5-7.html.
|
[19] |
Global concern on the orphan drug development[N].China High-Tech Industry Health(中国高新技术产业导报).2002-07-03(5).
|
[20] |
Zhang L.Orphan drug development prospect analysis[N].Med Econ News(医药经济报),2002-06-24(2).
|
[21] |
Gong SW,Xu Y,Zhang L.Study on evaluation indicator system of drug accessibility[J].Chin Health Econ(中国卫生经济),2011,30(5):72-74.
|
[22] |
Zhang RW,Hu SL.A comparative study of international price for pharmaceuticals medicine price[J].Chin Health Econ(中国卫生经济),2001,20(2): 26-28.
|
[23] |
Ding JX,Sun XD,Ji N,et al.Availability evaluation and safeguard legal system research for orphan drugs in US and China[J].Chin Pharm J(中国药学杂志),2011(14):1 129-1 132.
|
[24] |
Yang L,Hu SL,Gong YC.International experience of pharmacoeconomic evaluation in health decision-making[J].Chin Pharm(中国药房),2004(6):347-351.
|
[25] |
Hu JJ,Luo AQ,Xu P,et al.Analysis of international medical insurance status orphan drugs[R]. 2012年中国药学会药事管理专业委员会年会论文集(上册).Beijing:2012-08-11.
|
[26] |
Lin YH,Wu XM.Design of orphan drug industrial policy[J].Modern Management Sci(现代管理科学),2012(5):9-11.
|
[27] |
Li MY.Provide the necessary protection for rare diseases medical[N].People′s Political Consultative Daily(人民政协报),2010-03-10:(D02).
|
[28] |
Zhong X.Rare diseases is likely into health insurance directory next year[J].China Health Insurance(中国医疗保险),2012(8):71.
|
[1] | LIU Li, LIU Zijin, TANG Jun, HE Guangwei, LIU Weizhong. Optimized synthesis process of tofacitinib citrate[J]. Journal of China Pharmaceutical University, 2022, 53(6): 685-689. DOI: 10.11665/j.issn.1000-5048.20220606 |
[2] | WU Xufeng, CHAI Shiying, LIU Jianhong, WANG Zhihui, YIN Ruifeng, CAO Ruiwei, SUN Xinqiang. Improvement of synthetic route of brivudine[J]. Journal of China Pharmaceutical University, 2022, 53(1): 41-45. DOI: 10.11665/j.issn.1000-5048.20220106 |
[3] | WANG Dong, ZHONG Jian, WANG Ling, ZHOU Zhihui, JIANG Haiting, LUO Peng, WANG Xizhi, WANG Chongyi. Improved synthetic process of apremilast[J]. Journal of China Pharmaceutical University, 2021, 52(5): 536-540. DOI: 10.11665/j.issn.1000-5048.20210504 |
[4] | HAN Chengqun, ZOU Qiaogen, SUN Qian, XIA Yunyan. Improvement of synthesis process of mirabegron[J]. Journal of China Pharmaceutical University, 2020, 51(4): 449-453. DOI: 10.11665/j.issn.1000-5048.20200409 |
[5] | ZHANG Qiuyue, YOU Qidong, YANG Jinpeng. Process improvement on the synthesis of atomoxetine[J]. Journal of China Pharmaceutical University, 2019, 50(4): 405-409. DOI: 10.11665/j.issn.1000-5048.20190404 |
[6] | LIU Li, WANG Chen, LIU Lixin, JI Tingting. Improved synthesis of analgesic pentazocine[J]. Journal of China Pharmaceutical University, 2018, 49(5): 568-571. DOI: 10.11665/j.issn.1000-5048.20180508 |
[7] | MA Li, ZHANG Menghan, XU Zhiwei, SUN Ying′ai, ZHU Jing, HUANG Yingbo, ZHANG Dayong. A new synthetic process of dapagliflozin[J]. Journal of China Pharmaceutical University, 2017, 48(1): 42-45. DOI: 10.11665/j.issn.1000-5048.20170106 |
[8] | WEI Qingjie, QIAO Junhua, CHEN Jianjun, GAO Zhigang, LI Yaqing. An improvement for synthesis of ceftriaxone sodium[J]. Journal of China Pharmaceutical University, 2016, 47(2): 163-165. DOI: 10.11665/j.issn.1000-5048.20160206 |
[9] | Improve on the Synthetic Process of Bezafibrate[J]. Journal of China Pharmaceutical University, 2003, (3): 80-81. |
[10] | Improved Process of Nimodipine[J]. Journal of China Pharmaceutical University, 1998, (3): 82-83. |