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英美药品因安全原因撤市分析及对我国的启示 被引量:2

An analysis of the drug withdrawals due to safety in foreign countries and its enlightenment to our country
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摘要 对英、美两国药品撤市的特点进行比较分析,为我国药品监管制度的制定、完善及相关研究提供参考。我国药品撤回制度的制定、实施与完善应视药品满足市场需求程度的不同而分别借鉴英、美两国在药品撤市方面的管理方式进行。 We analyzed the characteristics of the drug withdrawals due to safety in UK and US. Our goal is to provide information for the establishment and perfection of drug regulation system policy and the related research. The way of drug safety management in UK and US is actually different. To establish and perfect the drug withdrawal system policy, we should regard the differences of drugs' degree and to satisfy the market demand, and learn from the US and UK.
出处 《中国新药杂志》 CAS CSCD 北大核心 2008年第17期1550-1552,共3页 Chinese Journal of New Drugs
关键词 药品撤市 药品监管 英国 美国 drug withdrawal drug regulalion UK US
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参考文献5

  • 1Michelle Meadows,沈璐.为何将药品撤出市场[J].中国药事,2004,18(5):320-322. 被引量:3
  • 2ABRAHAM J, DAVIS C. A comparative analysis of drugsafety withdrawals in the UK and the US (1971 - 1992) : Implications for current regulatory thinkingand policy[ J]. Soc Sci Med, 2005, 61 (5) :881 - 892.
  • 3BAKKE OM, MANOCCHIA M, DE ABAJO F, et al. Drug safety discontinuations inthe UK, US, and Spain from 1974 through 1993 : A regulatory perspective [J].Clin Pharm Ther, 1995,58 (1):108-117.
  • 4曹丽君,吴晔,邵蓉.美国药品召回制度及对我国的借鉴意义[J].中国药物警戒,2006,3(3):160-163. 被引量:12
  • 5JEFFERYS DB, LEAKEY D, LEWIS JA, et al. New active substances authorised in theUnited Kingdom bStwcen 1972 and 1994 [J]. British J Clin Pharm, 1998,45(2) :151 -156.

二级参考文献1

  • 1[1]FDA 21CFR7 Subpart C-Recalls (Including Product Corrections)-Guidance on Policy,Procedures and Industry Responsibilities[EB/OL].[ 2004-04-01].http://www.fda.com.

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