药品监管体制改革直接影响药品质量安全和医药创新活动,进而关系到公众用药可及性。基于对我国药品注册制度变迁、技术审评体系的变化,本文分析了药品审评审批制度变革对创新药物研发和新药技术转移的影响。创新药技术转移需求量及自由度的提升,将在我国新药创制过程、创新药研发中发挥良好的市场导向作用;并提出了基于上市许可持有人制度、区域差异、医保目录的创新药技术转移策略。 Drug regulatory system reform directly affects the quality and safety of pharmaceuticals and pharmaceutical innovation activities, and thus relates to the availability of public drugs. Based on the changes of the drug registration system and the system of technical review in our country, this paper analyzes the impact of the reform of drug examination and approval system on the research and development of innovative drugs and the transfer of new drugs. Innovative drug technology transfer demand and freedom to upgrade, will be in China’s new drug creation process, research and development of innovative drugs to play a good market-oriented role; and put forward based on the listing permit system, regional differences, health insurance directory of innovative drugs Transfer strategy.