Overview
ISO/TS 23303:2020 - Health informatics - Categorial structure for Chinese materia medica products manufacturing process - is a Technical Specification (first edition, 2020) that defines a formal categorial structure and domain constraints to represent the whole manufacturing process of Chinese materia medica (CMM) products. The document covers three primary process categories: processing, extracting, and preparation, and provides standardized terminology (characterizing categories) and semantic links to enable consistent metadata, process description, and data exchange. This specification is not applicable to Japanese traditional KAMPO medicinal products.
Key topics and technical requirements
- Defined scope: modeling the whole manufacturing process of Chinese materia medica products (from raw CMM to final product and packaging).
- Characterizing categories: formal definitions for terms such as Chinese materia medica (CMM), origin, variety, decoction piece, processing, processing method, adjuvant material, extracting, leaching, separating, concentrating, drying, refining, extractive, monomer, mixture, preparation, dose form, etc.
- Categorial structure: a minimal set of domain constraints to represent concept systems in the decoction/manufacturing field, enabling hierarchical categories and consistent classification.
- Semantic links: standardized directed relations between concepts (examples include use, is processed by, produce, precede, affect, result in, enhance, reduce) to express process flows and causal/associative relationships.
- Emphasis on metadata consistency for production management, quality control, and semantic interoperability in health informatics contexts.
Practical applications
- Standardizing production metadata and vocabulary for Chinese medicines manufacturing to improve quality management, traceability, and regulatory reporting.
- Enabling machine-readable process descriptions and interoperability between manufacturing systems, laboratory information systems, and health informatics platforms.
- Supporting development of ontologies, controlled vocabularies, and electronic documentation for decoction pieces, extractives, and Chinese patent medicines.
- Facilitating data analytics, process auditing, and metadata-driven decision-making in pharmaceutical manufacturing and research.
Who would use this standard
- Manufacturers of Chinese materia medica and Chinese patent medicines
- Quality assurance and regulatory compliance teams
- Health informatics specialists, ontology and metadata modelers
- EHR / LIMS / MES vendors integrating traditional medicine manufacturing data
- Researchers and institutions working on standardization and process analytics
Related standards
- ISO/TC 215 (Health informatics - committee responsible)
- References cited in the specification: ISO 18668-1, ISO 20333, ISO 17115 and other ISO health informatics terminologies used for alignment and interoperability.
Keywords: ISO/TS 23303:2020, Chinese materia medica, manufacturing process, categorial structure, health informatics, processing, extracting, preparation, semantic links, decoction piece, adjuvant material, metadata, interoperability.