[Trend analysis and regulatory strategies for traditional Chinese medicine formula granules].

With the advent of the "post-pilot era" of traditional Chinese medicine formula granules, there are still a series of policy, technical, and industrial issues that need to be addressed in their production, regulation, and application practices. This article systematically reviews the development history and relevant policy evolution of traditional Chinese medicine formula granules, and summarizes the current industrial status in terms of quality standards, medical insurance payments, and market landscape. Based on a comparative analysis and positioning discussion between traditional Chinese medicine formula granules and traditional herbal decoctions, it is believed that the following practical issues still exist in this field:(1)A reasonable competitive evolution mechanism has not yet been formed, making it difficult to "improve quality and efficiency" of products;(2)The number of national standards is limited, and local standards operate independently;(3)Production processes are relatively constrained;(4)There is a contradiction between fixed equivalents and fluctuations in raw materials;(5)Market positioning needs to be clarified, and medication scenarios are limited. Furthermore, based on the perspective of shaping a healthy ecosystem for the traditional Chinese medicine industry and promoting rational clinical use of traditional Chinese medicine, the following suggestions are put forward:(1)Guide the formation of a product-based competitive landscape for traditional Chinese medicine formula granules;(2)Promote the establishment of a comprehensive regulatory system for the entire production process of traditional Chinese medicine formula granules;(3)Conduct systematic research on the relationship between the equivalents and intake of formula granules;(4)Break through existing application scenarios and reasonably expand the application forms of formula granules.