江西省医疗机构中药制剂备案技术审评已有一定的技术审评标准和实践案例，对技术审评要求进行更深入的商榷和完善显得尤为重要。旨在深入探讨医疗机构中药制剂备案技术审评有关要求，为有效规范医疗机构中药制剂备案技术审评提供科学、合理的参考依据。通过对近5年来127件注册及备案申报项目的梳理及分析，包括传统工艺配制中药制剂的临床需求、医疗机构制剂发展面临的挑战以及技术审评对制剂发展的引导作用等方面展开分析，重点对技术审评要点（即处方组成、制备工艺、质量标准等）进行深入剖析，以期使药品技术审评要点在细化申报材料内容、规范注册申报资料完整性、统一审评审批尺度、提升注册（备案）技术审评能力等方面发挥更大作用。因此，合理的注册（备案）技术审评要点对于完善医疗机构制剂注册（备案）管理至关重要，能够引导医疗机构提升中药制剂研发水平，规范注册申报要求，保障制剂的安全性与有效性，促进医疗机构中药制剂的健康发展。

At present, there are certain technical review standards and practical cases for the technical review of traditional Chinese medicine preparation registration in medical institutions in Jiangxi Province. However, with the continuous development of traditional Chinese medicine and the increasingly updated clinical needs, it is particularly important to conduct more in-depth discussion and improvement of technical review requirements. The purpose of this article is to deeply explore the relevant requirements for the technical review of the filing of traditional Chinese medicine preparations in medical institutions, with a view to providing a scientific and reasonable reference basis for effectively standardizing the technical review of the filing of traditional Chinese medicine preparations in medical institutions. Through the sorting and analysis of 127 registration and filing applications in the past five years, including the clinical needs of traditional Chinese medicine preparations prepared by traditional techniques, the challenges faced by medical institutions in the development of preparations, and the guiding role of technical review in the development of preparations, the focus is on the key points of technical review (i.e. prescription composition, preparation process, quality standards, etc.) were analyzed in depth, with a view to making the key points of drug technical review play a greater role in refining the content of application materials, standardizing the integrity of registration application materials, unifying review and approval standards, and improving registration (filing) technical review capabilities. Therefore, reasonable registration (filing) technical review points are crucial to improving the registration (filing) management of medical institutions’ preparations. They can guide medical institutions to improve the research and development level of traditional Chinese medicine preparations, standardize registration application requirements, ensure the safety and effectiveness of preparations, and promote the healthy development of traditional Chinese medicine preparations in medical institutions.

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江西省药品监督管理局科研项目（2023GL30）