文章摘要
王廷梅.生物疗法监管问题及路径探索——以“魏则西事件”为视角[J].南京医科大学学报(社会科学版),2017,(1):26~30
生物疗法监管问题及路径探索——以“魏则西事件”为视角
Supervision and route search of biological therapy: From the perspective of “Wei Zexi incident”Wang Tingmei
投稿时间:2016-07-06  
DOI:10.7655/NYDXBSS20170106
中文关键词: 生物疗法  审批制  监管
英文关键词: biological therapy  approval system  supervision
基金项目:
作者单位
王廷梅 武汉大学法学院湖北 武汉 430072 
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中文摘要:
      生物免疫疗法作为当前医学科研热门,其监管问题随着“魏则西事件”进入公众视野。从最初的审批制到目前的备案制,生物疗法实际上一直处于“零”监管状态,从科研到临床应用的决定权基本掌握在医院手中,引发了大量的社会问题。良好的监管状态有利于科学的进步,尤其在涉及到公民生命健康权利的医学领域,更是十分关键。文章结合国内外立法现状及经验,以研析更适于目前国内的生物疗法监管路径。
英文摘要:
      Biological immunotherapy is a popular medical research, and its regulatory issues occur into public view because of the Wei Zexi event. From the initial approval system to the current record-keeping system, biological therapy has actually been in a “zero” state of supervision. Its discretion rests from research to clinical application are in the hands of the hospital, which causing a lot of social problems. A good state regulation is beneficial to scientific progress, especially in the medical field which related to the life and health of citizen. It is very crucial. In this paper, we combine the status quo of legislative experiences at home and abroad to research the better regulatory path of biological therapy that suited to China.
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