期刊文献+

我国罕见病立法刍议 被引量:4

下载PDF
导出
摘要 本文在分析问题的基础上,阐述了我国罕见病的立法基础与定位及立法原则,探讨了罕见病立法可能涉及的若干制度策略。要推动疾病研究、诊断和预防;鼓励孤儿药研发;加强对罕见病的社会保障;加强社会力量的参与和协同发展。
出处 《新西部(中旬·理论)》 2015年第8期75-76,81,共3页 New Western
基金 清华大学法学院--拜耳卫生法研究基金重点项目(编号:HLRC2013001)阶段性成果 国家留学基金资助
  • 相关文献

参考文献9

  • 1信枭雄,管晓东,陈敬,史录文.国内外孤儿药注册制度比较研究[J].中国药学杂志,2013,48(15):1323-1328. 被引量:18
  • 2Chenguang W, Dingguo L. Legislative efforts for rare disease in China--analysis of the legal grounds and call for a regulatory framework[J].R. Dir. sanit. Sho Paulo, 2013.1(14): 11-33.
  • 3新华网.应加快罕见病立法推动“孤儿药”研发-访全国人大代表刘革新[EB/OL].[2015.03.12].http://news.xinhuanet.com/health/20l5-03/06/c127551587.htm.
  • 4高菁阳.孤儿药研发亟待罕见病立法推动[EB/OL].[2015-06-20].http://www.hanjianbing.org/content/details102281.html.
  • 5程岩.罕见病法律制度的困境与出路[J].河北法学,2011,29(5):10-18. 被引量:27
  • 6Gostin L O. Public health law:power, duty, restraint[M]. Univ of California Press, 2008.
  • 7中国经济周刊.冰桶下的罕见病:治疗药物全靠进口[EB/OL].[2015-03-12].http://focus.news.163.com/14/0909/10/A5MNKKQS00011SM9.html..
  • 8柴月.论美国《孤儿药法案》及其启示[J].中国卫生法制,2015,23(4):3-7. 被引量:5
  • 9刘旭辉.“罕见病教育歧视第一案”引热议[EB/OL].[2015-06-12].http://www.chinanews.com/jk/2015/04-03/7184390.shtml..

二级参考文献48

  • 1TAO Y, SHAO Y F, ZHANG C, et al. The current situation of or?phan drug regulation in the United States[J]. 中国药学杂志,2001,36(9):634-636.
  • 2LIU Y C, DONGJ P. Studies on management status of rare disea?ses and orphan drug in european union[J]. 中国药学杂志,2012,47(5):395-398.
  • 3GONG S W. Study of management strategies of improoing access to orphan drugs in China[DJ. Wuhan: Huazhong University of Sci?ence and Technology, 2008.
  • 4Department of Health, T AIW AN. Introduction and current situa?tion of TAIWAN Rare Diseases Regulation[EB/OL].[2012-01- 31J. http://www.doh.gov.tw.
  • 5MA R, LI D G, ZHANG X, et al. Opportunities and challenges of rare disease prevention in China[J].中国循证儿科杂志,2011,6(2):81-82.
  • 6FDA. Orphan Drug Act[EB/OLJ.[2012-03-14J. http://www. fda. gov/RegulatorylnformationiLegislationiFederalFoodDrugand?CosmeticActFDCActiSignificantAmendmentstotheFDCActlOr?phanDrugActidefault. htm.
  • 7FDA. Priority NDA and BLA Approvals[EB/OLJ.[2012-05- 29J. http://www. fda. gov/Drugs/DevelopmentApprovalProcessl HowDrugsareDevelopedandApprovediDrugandBiologicApprov?alReports/PriorityNDAandBLAApprovalsl default. htm.
  • 8FDA. Drug and Biologic Approval Reports[EB/OL].[2012-05- 29]. http://www. fda. gov/Drugs/DevelopmentApprovalProcessl HowDrugsareDevelopedandApprovediDrugandBiologicApprov?aIReportsl default. htm.
  • 9FDA. About the Accelerated Approval Regulations[EB/OLJ .[2012-05-29J. http://www. fda. gov/Drugs/DevelopmentAp?provalProcess/HowDrugsareDevelopedandApprovediDrugandBio?logicApprovaIReportsl ucm121606. htm.
  • 10FDA. Accelerated and Restricted Approvals[EB/OL].[2012- 05 -29J. http://www.fda. gov/Drugs/DevelopmentApprovalPro?cess/HowDrugsareDevelopedandApprovediDrugandBiologicAp?provaIReportsl AcceleratedandRestrictedApprovalsl default. htm.

共引文献41

同被引文献45

引证文献4

二级引证文献19

相关作者

内容加载中请稍等...

相关机构

内容加载中请稍等...

相关主题

内容加载中请稍等...

浏览历史

内容加载中请稍等...
;
使用帮助 返回顶部