Analysis and reflection on the filing management of traditional Chinese medicine preparations in medical institu- tions
- VernacularTitle:医疗机构传统中药制剂备案管理工作的分析与思考
- Author:
Yatian WANG
1
;
Chao LI
1
;
Zhimei GUAN
2
Author Information
1. Hunan Center for Drug Evaluation and Adverse Reaction Monitoring，Changsha 410013，China
2. Hunan Center for Drug Inspection，Changsha 410013，China
- Publication Type:Journal Article
- Keywords:
traditional Chinese medicine preparations in medical institution;
traditional technology;
filing management
- From:
China Pharmacy
2022;33(3):263-270
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To compare and study the supporting policies for the filing man agement system of traditional Chinese medicine preparation prepared by traditional technology （hereinafter referred to as “TCM preparation ”）in medical institutions issued by the state and various provinces ，and their development ，so as to provide reference for the improvement of the follow-up supervision and management of the filing works. METHODS According to Announcement on the Filing Management of TCM Preparations Prepared by Medical Institutions Using Traditional Processes issued by former National Food and Drug Administration （hereinafter referred to as the Announcement）as well as notices and specific implementation rules issued by provincial bureaus ，the filing work data of 10 provinces in recent 3 years were selected for comparison ，sorting，statistics，classification and induction. The policy characteristics and progress of filing work were studied. RESULTS & CONCLUSIONS According to the local actual situation，some provinces had refined or expanded the contents of several parts of the Announcement，such as the scope of TCM preparations，the situation not allowed to record ，the filing process and working time requirements ，the disclosure ，change and cancellation of filing information ，and the implementation of supervision and management. The statistical results of filing data in 10 provinces showed that compared with 2019，the number of TCM preparation declared for filing and medical institutions declared for filing had increased with growth rate of 91.0％ and 48.8％ respectively in 2020. There is still room for improvement in the supporting policies for the filing of TCM preparations ，which can be optimized by referring to the features of some provinces ’ implementation policies ，refining the construction of norms and standards ，and strengthening the construction of regulatory system platform. It is necessary to optimize policy and strengthen the capacity building of reporting institutions in advance ；carry out daily supervision and control risk based on risk during the filing management ；emphasize follow-up supervision ，strengthen the construction of ADR monitoring system in medical institutions ，and carry out life cycle supervision and management constructively afterwards，in order to promote the further development of TCM preparations in medical institutions.
