中美欧新药上市加快审评审批政策研究

本文梳理了中国新药加快审评审批政策的演变、现状,以及美国、欧盟现行的政策,对比了中美欧加快政策的执行效果。与美、欧相比较,中国目前没有从药物研发到上市监管的全生命周期、"全覆盖"理念的加快审评审批政策;中国的新药加快审评政策由强调物质创新向强调药品临床价值转化,但加快审评政策之间适用条件重叠,政策联用时不能更好地加速药品上市;中国加快审评时长的中位值先升后降再升,标准审评时长的中位值趋势逐年上升,而美国、欧盟标准审评、优先审评时长整体呈下降趋势。我国新药上市获批的中位时间较长且逐年增加。建议积极推进药品审评审批制度改革以形成稳定成熟的监管体系,增加监管政策的灵活性,更新法律法规和修订技术指南等。

A policy study on NDA/BLA expedited pathways in China,US and EU

The evolution and current status of China’s new drug accelerated review and approval policy,as well as the expedited pathways in US and EU were introduced.Compared with US and EU,there is no"full coverage"concept pathways in China,in which the accelerating role covers from research to marketing.China’s expedited pathways has changed from emphasizing structure innovation to drug’s clinical value;however,the applicable conditions overlap in different pathways,which cannot actually speed up the regulatory approval.In China,the median time of expedited review durations rise first,and then decrease and rise again,and the median time of standard review durations have been increasing year by year,while the US and EU standards review and expedited review durations have generally declined.In China,the median approval time is also increasing.It is suggested that the reform of the drug review and approval should be actively promoted and a stable and mature regulatory system should be gradually formed,in order to increase the flexibility of regulatory policies,improve the revision of laws and regulations and update technical guidelines.