创新激励视角下的特殊审评与再评价的衔接研究——基于美国经验

发布时间：2018-04-21 19:22

  本文选题：特殊审评 + 加速审评　； 参考：《中国新药杂志》2017年22期

【摘要】：我国的药品特殊审评体系经过多年的发展取得了显著进展,但在审评质量和效率上同发达国家仍存在较大差距。本文深入分析我国特殊审评体系存在的问题,基于对美国特殊审评体系和上市后临床研究的经验借鉴,提出完善多通道的特殊审评体系并建立特殊审评与上市后再评价的衔接的具体建议,以期提升审评效率,激发创新热情。
[Abstract]:After years of development, China's special drug evaluation system has made remarkable progress, but there is still a big gap between China and the developed countries in the quality and efficiency of the evaluation. This paper deeply analyzes the problems existing in the special review system of our country, and draws lessons from the experience of the special review system in the United States and the post-market clinical research. In order to improve the efficiency of evaluation and stimulate the enthusiasm of innovation, the paper puts forward some concrete suggestions on how to perfect the special evaluation system of multi-channel and establish the link between special review and post-market re-evaluation.
【作者单位】： 中国药科大学国家药物政策与医药产业经济研究中心;
【基金】：国家社会科学基金重大项目——我国创新药物政策环境研究(15ZDB167) 中央高校基本科研业务费项目(人文培育):药品再评价法律制度研究(2016RPY003)
【分类号】：R95
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本文编号：1783779