Discussion on the Problems and Countermeasures of the Preparation Registration in Medical Institutions in Liaoning
10.6039/j.issn.1001-0408.2015.19.05
- VernacularTitle:辽宁省医疗机构制剂注册中存在的问题及对策探讨
- Author:
Sen HUANG
;
Chunli HU
;
Li WANG
;
Wenjuan SHEN
- Publication Type:Journal Article
- Keywords:
Medical institution;
Preparation registration;
Existing problems;
Suggestion
- From:
China Pharmacy
2015;(19):2608-2610
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To standardized declaration of preparation registration in medical institutions. METHODS:With the combination of registration review of new varieties in the preparation registration in medical institutions in Liaoning province from 2010 to 2014,the existing problems in drug registration information of preparation in medical institutions were introduced,and the solutions and suggestions were proposed. RESULTS & CONCLUSIONS:The main problems of registration information of prepara-tion in medical institutions included non-standardized preparation name,unclear topic and writing,inappropriate instructions and la-bels,and imperfect preparation process,etc. To standardize the preparation registration authenticity and integrity of registration in-formation of medical institutions,it is suggested to increase on-site verification efforts,strengthen the five years clinical using his-torical inspection,improve the level of research and development of hospital preparations declaration units,and strengthen the idea that the medical institutions should be responsible for the quality and safety of preparations to ensure the safety and effectiveness.
