ISO 11238:2018

Overview - ISO 11238:2018 (Health informatics - Identification of medicinal products)

ISO 11238:2018 defines an information model and data elements for the unique identification and exchange of regulated information on substances used in medicinal products (including dietary supplements, foods and cosmetics). Intended for use in both human and veterinary domains, the standard describes how to represent substances, relate specified substance groups, and reference external terminologies and molecular structure representations to support interoperable data exchange.

Key topics and technical requirements

• Information model and modelling principles: Conceptual, high-level and detailed diagrams illustrate classes, attributes, relationships, multiplicity, inheritance and notes to support consistent implementation.
• Substance identification concepts: Data elements required for unique identification and description of substances, including naming, identifiers and relationships between parent substances and specified substance groups.
• Types of substances covered: Chemical, protein, nucleic acid, polymer, structurally diverse substances, mixtures and common element sets (structure, isotope, modification, source material, taxonomy).
• Specified Substance Groups: Definitions and attributes for Specified Substance Groups 1–4, including group names, grades, analytical data, manufacturing and version/specification information.
• Identifiers and molecular representations: Guidance and references to existing identifiers and molecular structure formats (Annex A), such as CAS Registry Number, InChI/InChIKey, SMILES, Molfile, EC numbers, UNII and others.
• Message exchange and conformance: Guidance on message exchange format and conformance terminology to ensure interoperable exchange of regulated substance information.
• References to external resources: The standard references other standards and terminologies applicable to substance identification and exchange.

Applications - who uses ISO 11238 and why

• Regulators and health authorities: For consistent capture, exchange and regulation of substance information across submissions, pharmacovigilance and product registries.
• Pharmaceutical manufacturers and CROs: To model substance details (manufacturing, grades, analytical data) for product dossiers and supply chain traceability.
• Health IT vendors and EHR/ERP integrators: To implement interoperable data structures for medicinal product databases and drug information systems.
• Terminology and informatics teams: To map local substance identifiers to global identifiers (InChI, UNII, CAS) and maintain conformance to ISO modelling principles.
• Veterinary and food/cosmetic sectors: To reuse the same information model for non-human medicinal or related substance regulation and safety data.

Related standards

• ISO 11238 is part of the ISO identification of medicinal products (IDMP) suite and references ISO/TS 19844 and other terminology/structure standards for identifiers and molecular formats.

Using ISO 11238 helps organizations achieve consistent, machine-readable substance identification, improve regulatory exchange, and support pharmacovigilance and supply-chain transparency.