Overview
ISO/TR 23021:2018 - "Traditional Chinese medicine - Controlled vocabulary on Japanese Kampo crude drugs" provides a standardized, controlled vocabulary for crude drugs used in Japanese Kampo medicine. Published by ISO/TC 249 (Traditional Chinese medicine), the technical report defines names and concepts for Kampo crude drugs (as concepts/definitions) aligned with Japanese Pharmacopoeia (JP) and official Japanese crude‑drug standards. The aim is to improve safety, avoid ambiguity from synonyms/homonyms, and facilitate international trade and drug information management.
Key Topics
- Scope and exclusions: Applies to crude drugs as concepts used in Kampo formulae; excludes individual manufactured medicinal product names and materia medica or traditional medicines not regulated by the Japanese Pharmacopoeia or Japan’s Ministry of Health, Labour and Welfare.
- Controlled terminology: Authoritative Latin, English and Japanese names (with JP superscript convention) for Kampo crude drugs to distinguish Japanese definitions from other traditions.
- Terminology preparation: Guidance on preparatory work including target group delimitation, types and evaluation of reference sources, and systematic recording of terminological data.
- Terminological entries: Structure of entries covering backbone concepts, administrative information, identifiers (e.g., substance codes used in Japanese drug management and Japan standard commodity classification), and systematic ordering.
- Physicochemical identification: Requirements and examples (Annex A) for physicochemical identification as used in the Japanese Pharmacopoeia.
- Indices and lists: Term list and alphabetical indexes (Latin, English, scientific names) to support lookup and database mapping.
- Conformance: Expectations for manufacturers and stakeholders in Japan to use JP‑defined names on medicinal products based on Kampo formulae.
Applications
ISO/TR 23021:2018 is practical for:
- Regulators and policy makers ensuring consistent nomenclature and aligning domestic standards with international information exchange.
- Pharmaceutical manufacturers and packagers labeling Kampo-based products according to JP‑defined names for regulatory compliance and market access.
- Import/export and trade specialists reducing trade barriers through unambiguous drug naming.
- Clinical pharmacists and prescribers avoiding medication errors arising from synonyms/homonyms.
- Health informatics and drug‑information systems (EHRs, drug databases, LIMS) implementing standardized identifiers and vocabularies for interoperability and pharmacovigilance.
- Terminologists and standards developers building multilingual termbase entries and mapping between pharmacopoeias.
Related standards and context
- Prepared by ISO/TC 249 (Traditional Chinese medicine) and designed to conform with ISO deliverables on drug information management.
- Uses JP (Japanese Pharmacopoeia) and related official Japanese crude‑drug standards as primary references.
Keywords: ISO/TR 23021:2018, Kampo crude drugs, controlled vocabulary, Japanese Pharmacopoeia, Kampo medicine, drug nomenclature, traditional Chinese medicine, drug information management.