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.

Medical institutions  /  traditional crafts  /  Traditional Chinese medicine formulations  /  technical review  /  review points