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

Research on the link between expedited review and drug reevaluation from the perspective of innovation incentive based on American experience

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。

Expedited review in China has made a significant progress after years of development,but there＇s still a large gap in the quality and efficiency of the review compared with developed countries. This paper made an in-depth analysis of the existing problems of expedited review in China. Based on the experience from expedited review and post-marketing clinical study in the U. S.,specific suggestions were put forward to improve a multi-channel system of expedited review and establish the link between expedited review and post-marketing drug reevaluation. We expect the improvement of review efficiency and the inspiration of innovation enthusiasm through the suggestions provided by this paper.