[Exploration in similarities and differences in provincial standard conversion procedures for traditional Chinese...

The provincial standard conversion work for traditional Chinese medicine(TCM) formula granules is a crucial initiative to accelerate the industrial development of TCM formula granules and intensify scientific supervision. Currently, in the ongoing provincial standard conversion work of TCM formula granules in some regions, issues such as policy divergences and insufficient coordination have surfaced. By systematically reviewing the progress of standard conversion work, including the policy documents issued by drug regulatory authorities and the number of released trial conversion standards, in five provinces, namely Guangdong, Hebei, Jiangsu, Sichuan and Yunnan, this study conducted a comparative analysis across the dimensions of policy objectives, scope of application, basic procedures, core conversion conditions, requirements for application materials, review mechanisms and publicity details. This aimed to clarify their respective emphasis and differentiated characteristics. It also sorted out the quantity and dynamic trends of conversion standards in these five provinces, summarized the existing problems and development bottlenecks in the current conversion work, and put forward targeted approaches for policy optimization. The analysis of provincial policy differences and regulatory trends revealed the current structural contradictions, including difficulties in inter-provincial standard mutual recognition, constraints on the conversion of local commonly used varieties, poor adaptability in the conversion of varieties(e.g., mineral medicines) whose natural properties render them unsuitable for the preparation of formula granules, and inadequate cross-regional regulatory coordination. Furthermore, policy optimization suggestions were proposed, such as establishing an inter-provincial standard coordination mechanism, prioritizing the promotion of regional conversion and mutual recognition of local characteristic varieties, optimizing the conversion pathways for varieties with natural attributes unsuitable for formula granule production(such as mineral medicines), and deepening exchanges and cooperation among provincial-level regulatory authorities. This study provides a reference for advancing TCM formula granules from the stage of "one province, one standard" to the goal of "consistent quality nationwide", and holds practical significance for promoting the standardized and orderly development of the TCM formula granule industry.