Study on the current status and pathway optimization of traditional Chinese medicine preparations record-filing management in medical institutions across different provinces
- VernacularTitle:不同省份医疗机构传统中药制剂备案管理现状及路径优化研究
- Author:
Chao LIN
1
;
Chenjie SHU
2
;
Chuchu WAN
2
;
Yang DONG
2
;
Mengting DI
2
;
Huiying SHEN
2
;
Bo ZHANG
2
Author Information
1. Dept. of Pharmacy，Lishui Hospital of Traditional Chinese Medicine Affiliated to Zhejiang Chinese Medical University，Zhejiang Lishui 323020，China
2. Strategic Planning Division，Monitoring and Statistical Research Center，National Administration of Traditional Chinese Medicine，Beijing 100027，China
- Publication Type:Journal Article
- Keywords:
traditional Chinese medicine preparations;
record-filing system;
management status;
optimized pathway
- From:
China Pharmacy
2026;37(13):1673-1678
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To provide scientific reference for perfecting the record-filing management policy of traditional Chinese medicine preparations formulated via traditional processes for medical applications （hereinafter referred to as “TCM preparations”） in medical institutions， and further promote the sound development of the research and record-filing work of such preparations. METHODS A literature review combined with cross-sectional research was carried out. We collected policy documents and preparation information related to the record-filing of TCM preparations issued by national and provincial drug administration authorities on official websites during 2018-2025. A comparative analysis was conducted on the implementation and revision of core policy documents for the registration management of TCM preparations across provinces， the scope of record-filing dosage forms， conditions for rejection of record-filing， and exemptions for registration materials. Statistical analysis on the quantity and dosage forms of record-filing preparations in each province was conducted by means of data induction and trend chart plotting， and targeted suggestions were put forward to optimize the management pathway of record-filing. RESULTS CONCLUSIONS There was obvious heterogeneity in record-filing policies among provinces. Twelve provinces refined the applicable dosage forms for record-filing， fifteen provinces supplemented conditions for rejection of record-filing （16 items in total）， and nine provinces expanded the scope of material exemptions. The number of recorded preparations presented a striking regional imbalance：Qinghai had the largest quantity of 4 269 varieties， while Hainan only had 14 varieties， with a gap of more than 300 times. The recorded preparations were mainly traditional dosage forms including pills （6 928 varieties） and powders （4 360 varieties）. Only 12 provinces formulated the provincial catalog for TCM preparations allocation. In most regions， preparation circulation was only permitted within medical consortia， leading to a low transformation rate of scientific and technological achievements of preparations. It is recommended to optimize the record-filing management pathway from three aspects： strengthening policy standardization while maintaining flexibility， streamlining record-filing procedures and documentary requirements， and reinforcing technical support and achievement transformation. These measures can reduce regional policy differences， improve work efficiency of record-filing， and advance the standardized development and clinical value transformation of hospital-made TCM preparations.
