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入出境生物制品病毒安全性管理探讨 被引量:2

Discuss on virus safety management of entry-exit biological products
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摘要 文章通过分析国内外生物制品病毒安全性管理现状,探讨检验检疫部门对入出境生物制品病毒安全性管理需要关注的重点。提出检验检疫部门对入出境生物制品病毒安全性管理需要关注源材料的病毒安全性;进行入出境生物制品病毒安全性的追踪观察;开展入出境生物制品使用单位的分类管理;加强合作以提升检验检疫部门入出境生物制品病毒安全性监测能力。 By analyzing domestic and international viral safety management status of biological products, the article discussed what schould be focused on in virus safety management of entry-exit biological products for inspection and quarantine departments. The entry-exit biological products virus security management for inspection and quarantine department need to focus on the virus safety of the source materials, the tracking observation on the entry-exit of biological products viral safety, carrying out category management of unit using entry-exit biological products, strengthening cooperation and enhancing the capacity of inspection and quarantine departments to monitor entry-exit biological products virus safety.
出处 《南京医科大学学报(社会科学版)》 2014年第2期112-114,共3页 Journal of Nanjing Medical University(Social Sciences)
基金 江苏省软科学研究项目(BR2012052)
关键词 入出境生物制品 病毒 安全性管理 entry-exit biological products viral safety management
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  • 1[5]杜钢建.危机处置时的人权保护[N].法制日报,2003-5-15(8).
  • 2宋瑞霖.新世纪,新思路,新变化,新气象--新<药品管理法>颁布有感[J].中国药事,2001,15(2):76-77.
  • 3陈煜儒.大力加强公共应急法制建设--访中国人民大学法学院教授莫于川[J].卫生法学通讯,2003,5(8):8-9.
  • 4[4]Zhang JG.Viral safety for animal-derived products//British Council.China-UK Workshop on food safety,Zhengzhou,2006.Beijing:British Council Beijing Branch,2006:27-28.
  • 5[7]WHO.Requirements for the use of animal cells as in vitro substrates for the production of biologicals.WHO Technical Report Series,No.927,2005[EB/OL].[2007-03-23].http://www.who.int/biologicals/areas/blood_products/ANNEX%204%20Animal%20cellsP135-137.pdf.
  • 6[8]Committee for Proprietary Medicinal Products NOTE for guidance on virus validation studies:the design,contribution and interpretation of studies validating the inactivation and removal of viruses[EB/OL].(1996-02-14)[2007-03-23].http://www.emea.eu.int/pdfs/human/bwp/026895en.pdf.
  • 7[9]Committee for Proprietary Medicinal Products.NOTE for guidance on plasma-derived medical products[EB/OL].(2001-01-25)[2007-03-24].http://www.emea.eu.int/pdfs/human/bwp/026995en.pdf.
  • 8[10]ICH.Note for guidance on quality of biotechnological products:viral safety evaluation of biotechnology products derived from cell lines of human or animal origin[EB/OL].(2001-01-25)[2007-03-24].http://www.tga.gov.au/docs/pdf/euguide/ich/29595en.pdf.
  • 9[11]U.S.Department of Health and Human Services,Food and Drug Administration,Center for Biologics Evaluation and Research.Characterization and qualification of cell substrates and other biological starting materials used in the production of viral vaccines for the prevention and treatment of infectious diseases[EB/OL].(2006-09-28)[2007-03-19].http://www.fda.gov/cber/gdlns/vaccsub strates.pdf.
  • 10[12]Center for Biologics Evaluation and Research,Food and Drug Administration.Points to consider in the characterization of cell lines used to produce biologicals[EB/OL].(1993-06-12)[2007-03-20].http://www.fda.gov/cber/gdlns/ptccell.pdf.

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