2015年8月,国务院印发《关于改革药品医疗器械审评审批制度的意见》(国发[2015]44号),提出开展上市许可持有人制度试点,拉开了深化我国药品监管制度改革的大幕。此轮改革的目的不仅在于解决审评审批积压、申报资料质量不高、仿制药质量不高等实际问题,更在于建立一个 In August 2015, the State Council issued the Opinions on Reforming the Examination and Approval System of Medical Devices for Medical Products (Guo Fa [2015] No. 44), put forward the pilot scheme for carrying out the system of listing license holder, and opened the way to deepen the reform of China’s drug regulatory system The curtain. The purpose of this round of reform is not only to solve the backlog of reviews and approvals, the quality of application materials is not high, and the quality of generics is not high, but also to establish a