关键词: font-size:medium, ">医疗机构；中药制剂；注册申报；备案申报

Abstract: Objective：To provide reference for promoting the research and development of hospital traditional Chinese medicine (TCM) preparations and improving the relevant management rules. Methods： Measures for the Registration of Hospital Prepartaions and Detailed Rules for the Filing of Hospital TCM Prepartaions issued by the provincial drug regulatory depatments were sorted out to summarize the similarities and differences in the registration requirements of hospital TCM preparations and the filing requirements of hospital TCM preparations in various provinces and relavant suggestions were put forward. Results & Conclusion: The requirements for registration and filing application documents for hospital TCM preparations in various provinces are almost the same， but the registration of hospital TCM preparations requires more files， including application form for clinical research， site inspection， sampling inspection， etc. There are differences in the Detailed Rules for the Filing of Hospital TCM Prepartaions in various provinces， and based on the main difference， the writer proposes to specify the dosage forms applicable for filing， revise the document requirements for the declaration of 5-year history of prescription use， specify the number of clinical cases required per year， and standardize the collection of clinical data， etc.

Key words: Medical institution, Traditional Chinese medicine prepartaions;Registration application;Filing application