Recently, the State Administration for Market Regulation officially released the recommended national standard “GB/T 46940-2025 traditional Chinese medicine – Categories of traditional Chinese medicine (TCM) clinical terminological systems.” This standard was developed under the leadership of the Institute of Information on Traditional Chinese Medicine, China Academy of Chinese Medical Sciences, in collaboration with 71 experts from 43 institutions nationwide. It modifies and adopts ISO 19465:2017, establishing a classification framework for traditional Chinese medicine (TCM) clinical terminological systems comprising 17 top-level concepts. The standard aims to systematically address persistent bottlenecks in this field, including the lack of uniformity in TCM clinical terminology and the resulting challenges in computer-based recognition and understanding. It thus provides crucial standardization support for TCM electronic medical records, clinical research, and big data analysis. The standard is scheduled to officially take effect on April 1, 2026. Standardization of terminology is a fundamental prerequisite for the informatization of TCM. Throughout TCM clinical practice and its informatization process, long-standing issues such as “polysemy” and “semantic divergence” have severely hindered the in-depth exchange, integration, and utilization of clinical data. The absence of a unified and structured terminology system prevents computers from accurately “recognizing” and “processing” TCM-specific diagnostic and treatment information, thereby forming a core barrier to the digital transformation and intelligent advancement of TCM. The TCM clinical terminology system aims to systematically address these challenges by clearly defining concepts, establishing a classification framework, and creating semantic associations among concepts. The document is developed based on the long-term efforts of the Institute of Information on Traditional Chinese Medicine, China Academy of Chinese Medical Sciences, in advancing the “TCM clinical terminology system.” It conducts an in-depth analysis of various terminology resources in the field of TCM and draws upon the foundational framework of Systematized Nomenclature of Medicine Clinical Terms, an internationally widely adopted clinical terminology system, to innovatively construct a classification system that aligns with the theoretical and practical characteristics of TCM. This framework comprehensively covers all elements throughout the entire process of TCM clinical diagnosis, treatment, and documentation, establishing a total of 17 top-level concept categories (Fig. 1). It not only supports the standardized representation of TCM-specific professional terminology but also integrates nontechnical terms commonly found in electronic medical records, thereby achieving comprehensive coverage of TCM clinical information spanning theory and practice, diagnosis and treatment, and medications and instruments.Figure 1.: Categories of traditional Chinese medicine (TCM) clinical terminological systems. TCMCTS, traditional Chinese medicine clinical terminological systems.The release and implementation of this standard constitute a milestone in the field. It not only provides a unified and authoritative terminology “lexicon” and classification “framework” for the informatization of TCM—thereby establishing a core foundation for the interoperability and data sharing across various clinical information systems—but also enables structured TCM clinical data to be efficiently processed by computers. This facilitates the in-depth analysis of diagnostic and therapeutic patterns, thereby empowering clinical decision-making and efficacy evaluation. Furthermore, the systematic terminology framework supports the standardized inheritance of TCM knowledge and clinical experience, and through alignment with international standards, vigorously promotes the global dissemination and academic recognition of TCM. As the leading institution in research on TCM informatization standardization, the Institute of Information on Traditional Chinese Medicine, China Academy of Chinese Medical Sciences, has led the development and release of 6 national standards and 13 ISO international standards. The release of GB/T 46940-2025 signifies that TCM informatization standardization has reached a new milestone. In the future, the promotion and application of this standard are expected to substantially advance the standardized development of TCM hospital information systems, artificial intelligence–assisted diagnosis and treatment, and other related fields, thereby injecting robust momentum into the inheritance and innovation of TCM in the digital era. Acknowledgments We would like to express our gratitude to 71 experts from 43 different institutions who participated in the development of the standard. Statement of ethics None. Conflict of interest statement The authors declare that they have no conflicts of interest with regard to the content of this report. Funding source The national standard was supported by the Scientific and Technological Innovation Project of Information Traditional Chinese Medicine, China Academy of Chinese Medical Sciences (CI2021B002), and the Key Laboratory of TCM Language and Cognitive Artificial Intelligence, Institute of Information on Traditional Chinese Medicine, China Academy of Chinese Medical Sciences (ZZSYS-1901-CZ). Data availability statement Data sharing not applicable to this article as no datasets were generated or analyzed during the current study. Author contributions Lirong Jia drafted the paper and participated in the development of the standard. Bo Gao participated in the development of the standard. Haiyan Li led the development of the standard and guided the paper. Meng Cui led the development of the standard.
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