Analysis and Suggestions on National Drug Quality Disclosure System
- VernacularTitle:国家药品质量通告制度分析与建议
- Author:
Wen LIU
1
;
Jiong ZHU
1
;
Chong WANG
1
;
Zengyao HU
2
Author Information
1. National Institutes for Food and Drug Control，Beijing 102629，China
2. National Medical Products Administration，Beijing 100037，China
- Publication Type:Journal Article
- Keywords:
National drug quality disclosure system;
Drug quality;
Drug administration
- From:
China Pharmacy
2021;32(23):2817-2821
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE：To provide reference for further improving the national drug quality disclosure system. METHODS ： The national drug quality disclosure system was analyzed in respects of general information ，implementation procedure ， implementation situation and effects ，and existing problems. The improvement suggestions were put forward. RESULTS & CONCLUSIONS：The national drug quality disclosure system had gone through the bulletin stage ，notice stage and announcement stage. At present ，it had become drug regulatory measure with timely release ，rigorous procedures and sanctions. The process of national drug quality disclosure included five steps ，ie. informing the sampling enterprises of the fact that the drugs were unqualified，controlling the risk of unqualified drugs ，providing legal relief to the notified units ，preparing the contents of the national drug quality notice ，and releasing the national drug quality notice to the public. In recent years ，National Medical Products Administration had made greater efforts to release the national drug quality notice. The release of the national drug quality notice has played an important role on forcing drug manufacturers to improve drug quality and enhance the credibility of drug regulatory departments. However ，there are also some problems ，such as the non-conforming report is not delivered in time ，the tracing time for suspected counterfeit TCM pieces is too long ，and the provincial drug regulatory bureau does not strictly control the first trial of complaints. It is suggested that National Medical Products Administration strengthen the training ，review and punishment of provincial drug regulatory departments ；at the same time ，provincial drug regulatory departments also need to strengthen responsibility and business capacity-building ，pay attention to relevant work and strengthen daily supervision.
