种族差异性药物桥接境外临床研究数据辅助新药审评工作的启示——以盐酸胍法辛在日本上市为例

Enlightenment of racially-differentiated drugs bridging overseas clinical research data in the review of new drugs:marketing of guanfacine hydrochloride in Japan

近年来系列药政文件的出台,为加快境外获批创新药在中国的注册申请提供了政策支持。目前少有文献对种族差异性药物如何利用境外临床试验数据辅助新药评审工作进行研究。本文通过分析盐酸胍法辛在日本上市时引入美国临床试验数据所采用的桥接策略,结合我国实际审评政策,提出了此类在境外已经获批的具有种族差异性的药物在国内审评审批的策略建议。

In recent years,many drug administration documents have been issued to speed up the registration of imported innovative drugs in China.At present,few little literatures focused on ethnically differentiated drugs and how to use data from overseas clinical trials to aid drug review.When guanfacine hydrochloride marketed in Japan,the US clinical trial data were introduced the bridging strategy and adopted.Base on the actual review policy in China,strategy recommendations were proposed for the review and approval of drugs with ethnic differences that have been approved overseas.