OBJECTIVE To analyze the regulatory challenges arising from the transition of entrusted preparation of traditional Chinese medicine preparations in medical institutions of Zhejiang Province from a licensing-based management to a filing-based management system, and to explore a regulatory mechanism that ensures preparation quality and safety while adapting to the new management model.

METHODS Through retrieval and study of national and provincial policies and regulations, this paper reviewed the policy evolution of entrusted preparation of traditional Chinese medicine preparations in medical institutions after the implementation of the Traditional Chinese Medicine Law of the People’s Republic of China. It summarized the regulatory challenges under the filing system and proposed targeted countermeasures and recommendations for supervision.

RESULTS The filing-based system has shifted the regulatory focus from “ex-ante approval” to “interim and ex-post supervision”, with corresponding changes in regulatory priorities. Issues persist in entrusted preparation regarding quality consistency assurance, delineation of responsibilities between entrusting and entrusted parties, cross-regional and cross-departmental regulatory coordination, and digital traceability.

CONCLUSION It is recommended to establish a full-chain regulatory system encompassing filing review, process supervision, and risk management. Specific measures include developing a standardized system for extended oversight of entrusted parties, implementing a risk-based tiered and classified regulatory model, advancing full-process digital traceability, and utilizing real-world data for post-marketing re-evaluation. These efforts aim to promote the standardized and high-quality development of entrusted preparation of traditional Chinese medicine preparations in medical institutions of Zhejiang Province.