日本创新药物激励政策及实施效果研究

Research on Incentive Policies of Innovative Drugs in Japan and Its Effectiveness

为了给我国创新药物政策体系构建提供参考借鉴,梳理日本创新药物研发激励政策,并分析其实施效果。结果表明,日本创新药物研发激励政策包括研发扶持政策、注册审评政策和市场回报政策,在促进新药研发方面取得了良好的效果。在此基础上,提出构建我国创新药物研发激励政策体系的相关建议,即完善医药资本市场、优化审评审批制度及市场独占制度、促进创新药物的市场转化。

Objective： Provide a reference for building innovative drug policy system in our country.Methods ： Studyinginnovative drug R＆D incentive policies in Japan, and analyzing its effect.Results：It is showed that Japan＇s innovative drug R＆D incentive policieshad greatly promoted its research and development.Conclusion： It is recommended thatcompleting international multicenter clinical trial, optimizing approval system and market monopoly, promoting the transformation of innovative drugs market.