OBJECTIVE： To provide reference for improving registration regulation of medical institution preparation and promoting the development of it. METHODS： According to sorting out and summarizing the Medical Institution Preparation Registration Management Approach （trail） contents， for its shortcomings in terms of medical institution preparation definitions， related improvement suggestions were put forward. RESULTS & CONCLUSIONS： The Medical Institution Preparation Registration Management Approach （trail） has promulgated for 12 years from 2005 till now， existing shortcomings were that the definition of medical institution preparations was too wide， requirement on data of application and registration was less rigorous， regulation of clinical research was vague， clinical application re-evaluation was inadequate， disapproved case was lacked. In view of the above shortcomings， it is suggested to narrow the definition of medical institution preparations， modify the requirement on data of application and registration  specify the regulation of clinical research， add monitoring period for the new preparation and update the disapproved case， so as to improve the registration regulation of medical institution preparations and promote the development of preparations in medical institutions.