中美双报重点考量因素及申报策略建议

Key factors and strategies of drug application both in China and the United States

随着2017年中国加入国际人用药品注册技术协调会(ICH),中美双报已经成为了本土企业创新药申报的新趋势。首先,本文总结了当前中美双报的现状,截止目前我国已有52家本土企业在中美两国进行新药临床试验申请(IND),但是进行新药上市申请(NDA)的企业相对较少;其次,阐述了中美双报需要考虑的因素,如临床需求、产品研发周期、企业资金、医保政策等;最后,对本土企业中美双报进行策略建议,希望可以为药品成功申报提供支持。

With China’s joining in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use(ICH)in 2017,drug application both in China and the United States have become a new trend for Chinese enterprises to declare innovative drugs.This paper summarized the current situation of drug application in China and the United States.Up to now,52 Chinese companies have applied for clinical trial in China and the United States,but fewer companies have applied for new drug marketing.This paper also illustratesd the factors that need to be considered,such as clinical needs,product research and development cycle,corporate capital,and medical insurance policy,etc.Finally,strategy suggestions were provided to ensure successful application.