ISO 18668-4:2017

Overview

ISO 18668-4:2017 - Traditional Chinese medicine - Coding system for Chinese medicines - Part 4: Codes for granule forms of individual medicinals for prescriptions - provides a standardized digital coding list and structure for granule forms of individual medicinals for prescriptions (GFIMP). Part 4 encodes 777 granule-form medicinals and implements the coding rules defined in ISO 18668‑1. The standard is intended to support clinical use, research, teaching, statistics and management of TCM granule products.

Key topics and technical requirements

• Scope and content: Contains a table of 777 coded granule items (GFIMP) with identifiers, Latin and English names, Chinese names, medicinal parts and code strings.
• Coding structure: Uses a 17‑digit numeric code organized in 10 layers, following the hierarchy and rules set out in ISO 18668‑1.
• Coding principles:
  • Uniqueness - each variety and processed form maps to a unique code.
  • Scientificity - classification is grounded in botanical taxonomy, medicinal part and stable attributes.
  • Scalability - the structure allows expansion for future additions.
  • Compatibility - designed to align with existing international standards and product classification practices.
  • Stability - once assigned, codes remain unchanged unless the medicinal’s basic characteristics change; discontinued items retain their codes.
• Referenced requirements: ISO 18668‑1 (coding rules) is normative; the standard also cites alignment with classification practices such as GS1, CPC and barcode standards (e.g., ISO/IEC 15420) in its rationale.

Practical applications and who uses it

ISO 18668‑4:2017 is practical for:

• Healthcare organizations and dispensaries - accurate dispensing, EHR integration and reducing medication errors for TCM granules.
• Regulatory authorities and statistics bodies - standardized identifiers for market supervision, import/export classification and public health statistics.
• Manufacturers and pharmaceutical enterprises - product identification, inventory control, traceability and supply chain management.
• Researchers and educators - harmonized terminology for clinical studies, pharmacopeial research and teaching materials.
• IT vendors and informatics teams - integration into pharmacy management systems, barcode/QR code schemes and interoperable data exchange.

Benefits include improved traceability, consistent product identification across jurisdictions, and support for digitalization of Traditional Chinese Medicine supply chains and clinical workflows.

Related standards and interoperability

• ISO 18668‑1 (Part 1 - coding rules for Chinese medicines) - normative for structure and rules.
• Designed to be compatible with international product classification and barcode standards (e.g., GS1, ISO/IEC 15420) to facilitate integration into existing labelling and trade systems.

Keywords: ISO 18668-4:2017, Traditional Chinese medicine coding, GFIMP, granule forms coding, TCM standard, 17-digit code, ISO 18668-1.