ISO 18668-1:2016

Overview

ISO 18668-1:2016 - "Traditional Chinese medicine - Coding system for Chinese medicines - Part 1: Coding rules for Chinese medicines" defines a structured, scalable coding framework to uniquely identify Chinese medicinal materials. The standard covers decoction pieces, Chinese Materia Medica (CMM / raw materials) and granule forms of individual medicinals for prescriptions (GFIMP) (but excludes Chinese patent medicines). It is intended to support clinical medication, scientific research and teaching, statistics, management and international trade.

Keywords: ISO 18668-1, Traditional Chinese medicine coding, Chinese Materia Medica, decoction pieces, GFIMP, bar code, identification, standardization.

Key topics and technical requirements

• Coding principles: codes must provide uniqueness, scientific integrity, scalability, compatibility, and stability so that each medicinal variety and processed form has one persistent identifier.
• Layered coding technology: the code is built in multiple layers (Layer 1 to Layer 10) to represent product category, source, taxonomic grouping, processing and commodity attributes. Example layer definitions included in the standard:
  • Layer 1 (1 digit) - broad category (e.g., agriculture/forestry/animal/fishery = 0).
  • Layer 2 (1 digit) - product code for Chinese medicines (symbolized by 6).
  • Layer 3 (1 digit) - main medicinal source (1 = plant, 2 = animal, 3 = mineral, 4 = fungus, 5 = lichen, 6 = algae, 7 = mixed).
  • Layer 4 (3 digits) - subdivided code indicating family/group and serial number (plant families encoded systematically; animals/minerals follow analogous grouping rules).
• Structure and checks: the standard specifies code structure, detailed layer descriptions, a code table (Annex A) covering layers 4–9, and check‑digit calculation rules (Annex B). Informative examples are provided (Annex C).
• Normative references: interoperability with existing systems is emphasized (e.g., ISO/IEC 15420, GS1, United Nations CPC, GB/T 7635.1‑2002).

Applications and users

ISO 18668-1:2016 is practical for:

• Healthcare providers, hospitals and dispensaries - to ensure accurate dispensing and traceability.
• Pharmaceutical manufacturers and packagers - for product identification, inventory and supply‑chain management, and barcode integration.
• Regulators and quality control agencies - to track sources, monitor quality and support market supervision.
• Researchers, educators and statisticians - for standardized reporting, data aggregation and research reproducibility.
• IT and barcode solution integrators - to implement machine‑readable identifiers aligned with EAN/UPC and GS1 practices.

Benefits include improved digitalization, traceability, international trade consistency and safer medication use.

Related standards

• ISO/IEC 15420 (EAN/UPC bar code specification)
• GS1 general standards (barcode and product identification)
• United Nations Central Product Classification (CPC)
• GB/T 7635.1‑2002 (national product coding context)
• Other parts of ISO 18668 series: Part 2 (decoction pieces), Part 3 (CMM), Part 4 (GFIMP)

For implementers, ISO 18668-1 provides a scientific, extensible basis to standardize Chinese medicine identification and integrate it into global bar‑coding and information systems.