创新视角下药品特殊审评与再评价衔接研究——基于欧盟经验

Research on the link between expedited review and drug reevaluation from the perspective of innovation incentive based on the European Union’s 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的差距。本文深入分析我国特殊审评体系存在的问题,基于对欧盟特殊审评体系和上市后再评价的经验借鉴,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具体建议,以期提升审评效率,激发创新热情。

Expedited review system in China has made a significant progress after years of development.However,a large gap in the quality and efficiency of the review between developed countries and China still exists.This paper did an in-depth analysis on the existing problems of expedited review in China.Based on the experience from expedited review and drug post-marketing clinical study in the European Union,specific suggestions were put forward to improve a multi-channel system of expedited review and the link between the two was established.We expect for the improvement of review efficiency and the inspiration of innovation enthusiasm through the suggestions.