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渐进式变迁——美英两国药品政府规制的百年演进(10)
http://www.100md.com 2005年6月10日
     注释:

    [1] 本文出处:John Abraham:Partial progress? -The development of American and British drug regulation, Science, Politics and the Pharmaceutical Industry: Controversy and bias in drug regulation, VCL press limited,1995,1st edition, page 36-86。译者把这本著作的中文译名译作《科学,政治和医药产业:药品规制中的悖论与偏见》。同时本文翻译已获原作者John Abraham博士授权,并承蒙其提供背景资料,在此谨致谢意。同时,感谢中化贸易出口公司王勤小姐为译者在国家图书馆查找邮寄相关资料,感谢华东政法学院孙潮教授、朱芒副教授对本文进行的详尽而认真的评论,感谢中国药科大学药事法规教研室陈永法博士对译文部分内容的审校。
, 百拇医药
    本文从比较法的视角,在对英美两国政治、经济、社会背景进行深入考察的前提下,对两国药品政府管制的历史进行了详尽而不拖沓的精彩描述。某种意义上,也是一篇对英美药品百年立法史的梳理,在本文结论部分,作者更凝炼出对政府管制理论,对药品立法的反思。对于有志于政府管制和行政法学研究的学人而言,这是一篇不可多得的精彩文章。

    [2] 作者约翰·亚伯拉罕(John Abraham),理学学士 (Sussex),理学硕士 (Sussex),文学硕士(Sussex),哲学博士 (Sussex) 。英国Sussex大学社会学教授,他教授药品、国家和社会,药品、健康和发展,社会学分析原理,科技和社会等课程。主要研究兴趣是科技和医药的政治经济学;对技术风险的规制,特别是英国、美国、欧盟和东欧的药品规制。主要著作有Science, Politics and the Pharmaceutical Industry[科学,政治和医药产业] (1995), London/New York: UCL/St Martins Press; The Therapeutic Nightmare: The Battle Over the World’s most Controversial Sleeping Pill[治疗的噩梦:世界上最具争议的催眠药] (1999), London: Earthscan; Regulating Medicines in Europe[欧洲药品规制] (2000), London: Routledge; Regulation and Innovation in the Pharmaceutical Industry [医药产业的规制和创新](2000), London: Macmillan.作者电子邮件地址:J.W.Abraham@sussex.ac.uk。 在此需要说明的是,本文尽管是英美两国药品管制历史的比较研究,但由于作者系英国学者,文中对英美两国的关注程度并不相同,不难发现作者是怀着浓重的英国问题意识进行此项比较研究的。
, http://www.100md.com
    [3] 中国药科大学药事法硕士(2000届),现研究方向:政府管制和行政法学,药品管制。E-mail地址:songhualin77@21cn.com

    [4] J.Liebenau 1981.Medical science and medical industry 1890-1929:a study of pharmaceutical manufacturing in Philadelphia. PhD thesis, University of Pennsylvania.

    [5] ABPI 1984.Dr John Griffin takes over as ABPI Chief. ABPI News 198,1;ABPI 1984. New ABPI director stresses importance of two-way flow between medicines division and industry. ABPI News 198,3.
, 百拇医药
    [6] ABPI 1972. Review of the year: Medicines Act 1968. ABPI annual report 1971-72,5.London: ABPI.

    [7] J.Collier 1989. The health conspiracy. London: Century.

    [8] J.Liebenau 1981.Medical science and medical industry, 89. London: Macmillan; J. Braithwaite 1986. Corporate crime in the pharmaceutical industry, 298.London: Routledge&Kegan Paul.

    [9] United States Office of Government Ethics 1979. Summary of the post-employment restrictions of the Ethics in Govennment Act of 1978 and important interpretations in the regulations. Washington DC: US Government Publications Office.
, 百拇医药
    [10] ABPI 1972. Review of the year: Medicines Act 1968. ABPI annual report 1971-72,5.London: ABPI.

    [11] R.Hurley 1983. The Medicines Act-is it working? Journal of the British Institute of Regulatory Affairs(BIRA) 2,3.

    [12]BMA 1976. Pharmaceutical industry. British Medical Journal 278,1397. PSGB 1976.CSM asked to speed up procedures. Pharmaceutical Journal 217,46.

    [13]J.P.Griffin&J.R.Long 1981. New procedures affecting the conduct of clinical trials in the United Kingdom. British Medical Journal 283,477.
, 百拇医药
    [14] PSGB 1979. ABPI Produces New Code of Advertising Practice. Pharmaceutical Journal 3 March 78; ABPI 1978. Advertising Regs: Government pushes them through.ABPI News 172,1.

    [15] A.M.Schmidt 1975.The commissioner’s report of investigation of charges from Joint Hearings.901.Washington DC: US Government Publications Office.

    [16] US Department of Health and Human Services 1987.All about FDA: an optimization handbook, 47-49.Rockville, Maryland: FDA.

    [17] R.G.Penn 1980. The drug industry. British Medical Journal 281,1563-4.

    [18] J.Smith 1980.Drug famine: possible solutions.British Medical Journal 281,1476.

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