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浅析中美药械组合产品的监管对策 被引量：6

Supervisory Measures of Combination Products in Sino US
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摘要 通过汇总2009-2013年组合产品办公室（OCP）向美国国会提交的组合产品年度报告中的数据,分析近年来美国食品和药物管理局（FDA）组合产品的申报情况,并研究FDA对药械组合产品的监管模式,汇总分析2009~2014年我国药械组合产品属性界定的申请情况,总结中美两国对药械组合产品监管上的区别,分析我国药械组合产品监管中存在的问题,为加强此类产品的监管工作提供参考。 This paper summarizes the datas in the annual office of combination products （OCP） performance report to American congress from 2009 to 2013, analysis the attribute conditions to the combination products designation in the recent years of US. Studies the united states＇supervision mode on such products. Summarizes and analysis the attribute conditions to the drug and medical device combination products designation from 2009 to 2014. Summarizes the differents in the management of combination products between the two countries and the problems in our country, to provide some certain references for strengthening such products＇ supervision work.
作者 王海燕
机构地区 国家食品药品监督管理总局行政事项受理服务和投诉举报中心
出处 《中国药物评价》 2015年第3期175-180,共6页 Chinese Journal of Drug Evaluation
关键词 药械组合产品 分配申请 监管 Drug and meidcal device combination products Request for designation Supervision
分类号 R95 [医药卫生—药学]
  • 相关文献

参考文献18

  • 1国家食品药品监督管理局,关于药械组合产品注册有关事宜的通告[EB/OL].http://www.sfda.gov.cn/WS01/CL0087/43215.html.
  • 2US FDA. CFR-Code of Federal Regulations Tide 21 [ EB/OL]. [2014-04- 01]. http://www, accessdata, fda. gov / scripts / cdrh / cfdocs / cfcfr / CFRSearch. cfmfr = 3. 2.
  • 3Margaret A. Hamburg. FY2013 OCP Performance Report [EB/OLI. [2015-03- 23]. http://www, fda. gov/AboutFDA/ReportsManualsForms/Reports/Perfor- manceRepar ts/CombinafionProducts/ucm439382, htm.
  • 4US FDA. How to Write a Request for Designation (RFD) [ EB/OL]. [ 2014-08- 05 ]. http://www, fda. gov/RegulatoryInformation/Guidances/ucm126053. htm.
  • 5US FDA. Examples of Combination Product Approvals[EB/OL]. [2010-07- 15]. http://www, fda. gov/ ucm101598, htm.
  • 6US FDA. Submission and Resolution of Formal Disputes Regarding the Timelihess of Premarket Review of a Combination Product[ EB/OL]. [2014-08-26]. http://www, fda. gov/Regulatorylnformation/Guidances/uem126006, htm.
  • 7US FDA. Application User Fees for Combination Products[EB/OL]. [2014-08- 05 ]. http ://www. fda. gov/Regulatorylnformation/Guidanees/uem126017. htm.
  • 8US FDA. Early Development Considerations for Innovative Combination Prod- ucts[EB/OL]. [2014-08-05]. http://www, fda. gov/Regulatorylnformation/ Guidances/ucm126050. htm.
  • 9US FDA. Devices Used to Process Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) [ EB/OL]. [ 2014-08-05 ]. http:// www. fda. gov/RegulatoryInformation/Guidances/ucm126052, htm.
  • 10US FDA. New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products [ EB/OL ]. [ 2009-12 ]. http :// www. fda. gov/downloads/RegulatoryInformation/Guidances/UCM195951. pdf.

二级参考文献15

  • 1[7]European Commission.PART 2 Guidelines for the Classification of Medical Devices(EU MEDDEV 2.4/1)(Z),Jul 1,2001.
  • 2[1]US FDA.Medical Device User Fee and Modernization Act (MDUFMA) of 2002[z].http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/ucm109135.pdf,PUBLIC LAW 107-250-OCT.26,2002.
  • 3[2]US FDA.Definition of Primary Mode of Action of a Combination Product[Z].http://edocket.access.gpo.gov/2005/pdf/05-16527.pdf,August 25,2005.
  • 4[3]US FDA.Manual of Standard Operating Procedures and Policies/Intercenter Consultative/Collaborative Riview Process[Z].June 18,2004.
  • 5[5]European Commission.Council Directive 93/42/EECconcerning medical devices.[Z]http://www.mdss.com/MDEV/93 42 EEC.htm,June 14,1993
  • 6[6]European Commission.Draft Commission Proposal,COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices[Z].http://europa.eu.int/comm/enterprise/medical devices/consult.htm,April 5,2005.
  • 7国家食品药品监督管理局,关于药械组合产品注册有关事宜的通告(2009年第16号).2009.
  • 8USA,FDA,Frequently Asked Questions About Combination Products.http://www.fda.gov/CombinationProducts/AboutCombinationProducts/ucm101496.htm.
  • 9Nguyenl,K.L.a.T.,Combination Products Regulation at the FDA.Clinical pharmacology & Therapeutics,2009.58(5):p.468-470.
  • 10USA,FDA,Office of Combination Products.http://www.fda.gov/AboutFDA/CentersOffices/OC/OfficeofScienceandHealthCoordination/OfficeofCombinationProducts/default.htm.

共引文献10

同被引文献20

引证文献6

二级引证文献16

中国药物评价
2015年 第3期

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