Discussion on Relevant Issues of Medical Institution Preparation Registration Management Approach( Trial)
10.6039/j.issn.1001-0408.2017.25.05
- VernacularTitle:对《医疗机构制剂注册管理办法(试行)》有关问题的探讨
- Author:
Xiaoli SHEN
- Keywords:
Medical Institution Preparation Registration Management Approach;
Medical institution preparation;
Application and registration;
Shortcoming;
Suggestions
- From:
China Pharmacy
2017;28(25):3471-3474
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To provide reference for improving registration regulation of medical institution preparation and pro-moting the development of it. METHODS:According to sorting out and summarizing the Medical Institution Preparation Registra-tion Management Approach(trail)contents,for its shortcomings in terms of medical institution preparation definitions,related im-provement suggestions were put forward. RESULTS & CONCLUSIONS:The Medical Institution Preparation Registration Manage-ment 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 re-search was vague,clinical application re-evaluation was inadequate,disapproved case was lacked. In view of the above shortcom-ings,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.
