关键词: font-size:medium, ">传统工艺配制中药制剂备案制度；医疗机构制剂；风险管理

Abstract: Objective：To analyze the risk factors in the implementation of the record system of traditional Chinese medicine preparations by comprehensive risk management theory， so as to improve the safety and effectiveness of the application of traditional Chinese medicine preparations. Methods：Risk attribution and types were analyzed from the perspective of comprehensive risk management， and risk prevention and control strategies were proposed from different dimensions. Results：Different subjects need to improve their understanding of the risk prevention and control of TCM preparations under the filing system， and further improve the process management of the filing system. Conclusion：From the perspective of comprehensive risk management， the management mechanisms of regulatory agencies mainly include supervision and management， electronic filing， emergency warning， management incentive， and risk assessment. The management mechanism of medical institutions mainly includes internal supervision， personnel specification， production quality and dynamic monitoring. The management mechanism of laws and regulations mainly includes technology orientation， risk definition and unity of power and responsibility.

Key words: font-size:medium, ">Traditional Chinese medicine preparation record system；Preparations made by medical institutions；Risk management