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

作　　者：陈卫霖 吴明如 葛卫红[1] CHEN Wei-lin;WU Ming-ru;GE Wei-hong(Nanjing Drum Tower Hospital of China Pharmaceutical University,Nanjing 210008;School of Basic Medicine and Clinical Pharmacy,China Pharmaceutical University,Nanjing 211198)

机构地区：[1]中国药科大学南京鼓楼医院,南京210008 [2]中国药科大学基础医学与临床药学学院,南京211198

出　　处：《中南药学》2021年第1期162-167,共6页Central South Pharmacy

摘　　要：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.

关 键 词：种族敏感性 桥接策略 创新药 盐酸胍法辛 注册审评 

分 类 号：R95[医药卫生—药学]