ISO/TS 19844:2018

Overview

ISO/TS 19844:2018 - “Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11238” provides practical, element‑by‑element guidance for implementing ISO 11238. It explains how to define and uniquely identify Substances and Specified Substances based on their scientific identity (what they are), rather than use or manufacture. This technical specification supports exchange of regulated substance information by detailing data elements, structures, examples and business rules to implement the IDMP conceptual model.

Key points:

• Implementation guidance for ISO 11238 (IDMP substance model)
• Third edition: addresses Specified Substances Groups 1–3 and Annexes A–K
• Explains data elements, logical usage, examples and identifier‑assignment triggers
• Clarifies what it does not cover (see Related Standards / exclusions)

Key topics and technical requirements

ISO/TS 19844 provides detailed coverage of the data and rules needed to represent substances consistently:

• Substance identification: substance type, substance ID and versioning rules
• Names and naming context: substance name, name type, language, jurisdiction, official names
• Reference sources: citation, source type, IDs and URLs for provenance
• Coding: code, code system, code system ID and status
• Structural information: stereochemistry, molecular formula, structural representations, isotopes
• Quantities and amounts: quantity, limits, units and non‑numeric values
• Source material and biologicals: organism, part, development stage, parent substance
• Modifications and properties: chemical/physical modifications, property types and values
• Substance definitions by class: chemical substances, proteins/peptides, nucleic acids (with examples)
• Business rules: when specific elements are required, how to distinguish materials, and triggers for assigning identifiers

The document is explicit about exclusions: it does not specify data management processes, database schemas, messaging standards, controlled vocabulary maintenance, the global identifier system to use, or substance nomenclature standards.

Applications and who uses it

ISO/TS 19844 is used to implement interoperable substance datasets across regulatory and industry systems. Typical users:

• Regulatory authorities assessing or exchanging substance data
• Pharmaceutical companies and regulatory affairs teams preparing submissions
• Pharmacovigilance and safety databases that need precise substance identifiers
• Health IT vendors and implementers building IDMP‑compliant data models or APIs
• Master data management and terminology specialists aligning substance metadata

Practical benefits:

• Improves consistency of substance identification and provenance
• Enables automated exchange of regulated substance information
• Reduces ambiguity in safety reporting, submissions and product registries

Related standards

• ISO 11238 (primary substance conceptual model for IDMP)
• ISO IDMP family (Identification of Medicinal Products) - ISO conceptual framework for regulated medicinal product information

Keywords: ISO/TS 19844:2018, IDMP, ISO 11238, substance identification, data elements, health informatics, medicinal products, regulatory data standards.