ISO/TS 20440:2023

Overview

ISO/TS 20440:2023 - Health informatics - Implementation guidelines for ISO 11239 - provides implementation guidance for data elements and structures used to uniquely identify and exchange regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging. It explains how harmonised controlled terminologies should be constructed, versioned and maintained, and describes how regional terminologies can be mapped to a standard coded set. The technical specification supports use of the resulting codes in regulated identifier fields such as PhPID, PCID and MPID.

Key topics and technical requirements

• Controlled vocabularies and coded concepts: Defines the code‑term pair and coded concept data types used to represent terms in specific language/region combinations.
• Organization of controlled terms: Guidance on term attributes (identifier, textual term, definition, domain, comments, language/region) and their use in databases.
• Versioning: Rules for versioning individual terms and whole terminologies to track creation and evolution over time.
• Terminology schemas: Structured schemas and examples for pharmaceutical dose form, combined dose forms, unit of presentation, route of administration and packaging.
• Mapping regional terminologies: Principles to map existing regional vocabularies to harmonised controlled terminologies, including handling differences in granularity and versioning of mapped terms.
• Practical examples: Illustrative examples (e.g., prolonged‑release tablet, ampoule, syringe) to clarify schema usage.
• Non‑prescriptive: The document provides implementation guidelines but does not mandate a specific terminology; it supports the development and maintenance of harmonised lists.

Applications and who should use it

This technical specification is intended for:

• Standards and terminology maintainers developing harmonised controlled vocabularies for medicinal products.
• Regulatory authorities and software vendors integrating standard vocabularies into regulatory submission, pharmacovigilance or e‑health systems.
• Database owners who need to map local terms to standardized coded concepts.
• Health informatics architects and implementers working on IDMP-related interoperability, product identification and regulatory exchange.

Practical benefits include consistent identification of dose forms and packaging across regions, improved interoperability for regulatory exchanges, and clearer mapping strategies to migrate regional terminology sets.

Related standards

• ISO 11239 (data elements and structures for dose forms, presentation units, routes and packaging) - ISO/TS 20440:2023 provides implementation guidance for ISO 11239.
• Supports broader IDMP (Identification of Medicinal Products) implementation efforts.