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DING Zhichen, WEI Guan, DING Jinxi. Orphan drug regime in Japan and enlightenment on China:based on evaluation of orphan drug access in Japan[J]. Journal of China Pharmaceutical University, 2014, 45(1): 118-124. DOI: 10.11665/j.issn.1000-5048.20140122
Citation: DING Zhichen, WEI Guan, DING Jinxi. Orphan drug regime in Japan and enlightenment on China:based on evaluation of orphan drug access in Japan[J]. Journal of China Pharmaceutical University, 2014, 45(1): 118-124. DOI: 10.11665/j.issn.1000-5048.20140122
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Orphan drug regime in Japan and enlightenment on China:based on evaluation of orphan drug access in Japan

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  • With Japan as the target for reference and on the basis of systematic analysis of orphan drug regime in Japan, this paper analyzed orphan drug regime in Japan from the aspects of pre-approval designation, approving and marketing phase and post-marketing administration, and also provided the corresponding operating performance evaluation. The study results indicated that the mature orphan drug system in Japan has yielded good effects in that it has effectively facilitated orphan drug R&D and improved the access, thereby providing referable and valuable theoretical foundation for the construction of orphan drug regime in China.
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    • References (20)
  • [1]
    Ding JX,Luo XW,Wang YW.Evaluation of Japanese data protection system from the perspective of economics—the empirical analysis based on the performance of reexamination policy on Japanese innovative drugs[J]. Shanghai Med Pharm J(上海医药),2011.32(12):615-620.
    [2]
    唐闻佳.“孤儿药”谁来“抱”? 罕见病患者看到未来曙光[EB/OL].(2012-03-02)http://sh.eastday.com/m/20120302/u1a6397098.html
    [3]
    Minghetti PM,Giudici EM,Montanari L.A proposal to improve the supply of orphan drugs[J].Pharmacol Res,2000,42(1):33-37.
    [4]
    Uchida K.Orphan drugs in Japan[J]. Drug Inf J,1996,30(1):171-175.
    [5]
    Tao Y,Bu YF,Zhang C,et al.Orphan drug management systems in Japan(日本的罕用药管理制度)[J]. Chin Pharm J(中国药学杂志),2002,37(6):468-470.
    [6]
    Shah RR.Chapter 11 Regulatory framework for the treatment of orphan diseases[EB/OL].http://www.ncbi.nlm.nih.gov/books/NBK11567/.
    [7]
    Scott DL,Alder S,Usui E,et al.Orphan drug programs/policies in Australia,Japan,and Canada[J].Drug Inf J,2001,35(1):11-13.
    [8]
    Gong SW. Management strategies of improving orphan drugs accessibility 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.
    [9]
    Yang L,Chen YW,Huang Z,et al.Research on the orphan drug exclusivity system[J].Chin Pharm Aff(中国药事),2010,24(1):49-52.
    [10]
    Villa S,Compagni A,Reich MR.Orphan drug legislation:lessons for neglected tropical diseases[J].Int J Health Plann Manage,2009, 24(1):27-42.
    [11]
    Zhang KJ.Interpretation and reflection on fast tract review in drug registration in developed countries[J].China Prescr Drug(中国处方药),2009,(90):66-67.
    [12]
    Pharmaceuticals and Medical Devices Agency. Profile of services 2013-2014[EB/OL].[2013-12-20]. http://www.pmda.go.jp/english/about/pdf/profile_of_services.pdf.
    [13]
    MSF.Data exclusivity in international trade agreements:What consequences for access to medicines[EB/OL]?[2013-12-20]http://www.citizen.org/documents/DataExclusivityMay04.pdf.
    [14]
    Guo Y,Zhang HL,Chen J,et al.Drug price policies in Japan and its enlightenment to China(日本药品价格政策研究及对我国的启示)[J].China J Pharm Econ(中国药物经济学),2010(4):63-67.
    [15]
    Tao Y,Shao YF,Zhang C,et al.History and current status of orphan drug administration in the U.S.(美国罕用药管理的历史与现状)[J]. Chin Pharm J(中国药学杂志),2001,36(9):634-636.
    [16]
    Guan XD,Shi LW.Establishment of national essential drug policies(建立我国国家基本药物政策的研究)[J]. Chin Pharm J(中国药学杂志),2009,44(2):158-160.
    [17]
    Li HT.Discussing the drug′s accessibility in China[J].Chin Health Serv Manage(中国卫生事业管理),2009,26(9):612-614.
    [18]
    Feng JH.The crises of public health,access to pharmaceuticals and its parallel import[J].J Law Appl(法律适用),2004,(12):15-18.
    [19]
    Ding JX,Zhao M.The comparative study on supervision and incentive policies of Sino-US during the innovative drug R&D[J].China J New Drug(中国新药杂志),2009,18(5):387-392.
    [20]
    Wu SY,Zhang K.Establishment of rare disease research and preventive strategies(关于建立罕见病研究和防治策略的思考)[J].Chin Health Resour(中国卫生资源),2011,14(5):317-319.
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