prCEN/TS ISO 21405

SLOVENSKI STANDARD
01-februar-2026
Zdravstvena informatika - Identifikacija medicinskih izdelkov - Metodologija in
okvir za razvoj in predstavitev ontologije IDMP (ISO/DTS 21405:2025)
Health informatics - Identification of medicinal products - Methodology and framework for
the development and representation of IDMP ontology (ISO/DTS 21405:2025)
Medizinische Informatik - Identifikation von Arzneimitteln - Methodik und
Rahmenbedingungen für die Entwicklung und Darstellung der IDMP-Ontologie (ISO/DTS
21405:2025)
Informatique de santé - Identification des médicaments - Méthodologie et cadre pour le
développement et la représentation de l’ontologie IDMP (ISO/DTS 21405:2025)
Ta slovenski standard je istoveten z: prCEN/TS ISO 21405
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

FINAL DRAFT
Technical
Specification
ISO/DTS 21405
ISO/TC 215
Health informatics — Identification
Secretariat: ANSI
of medicinal products —
Voting begins on:
Methodology and framework for the
2025-11-28
development and representation of
Voting terminates on:
IDMP ontology
2026-02-20
Informatique de santé — Identification des médicaments
— Méthodologie et cadre pour le développement et la
représentation de l’ontologie IDMP
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/CEN PARALLEL PROCESSING LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
ISO/DTS 21405:2025(en) © ISO 2025

FINAL DRAFT
ISO/DTS 21405:2025(en)
Technical
Specification
ISO/DTS 21405
ISO/TC 215
Health informatics — Identification
Secretariat: ANSI
of medicinal products —
Voting begins on:
Methodology and framework for the
development and representation of
Voting terminates on:
IDMP ontology
Informatique de santé — Identification des médicaments
— Méthodologie et cadre pour le développement et la
représentation de l’ontologie IDMP
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
© ISO 2025
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/CEN PARALLEL PROCESSING
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
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Published in Switzerland Reference number
ISO/DTS 21405:2025(en) © ISO 2025

ii
ISO/DTS 21405:2025(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Benefits of an ontological approach for IDMP . 4
4.1 General .4
4.2 Recommended methodology for collaborative IDMP ontology development – Ontology
governance in a collaborative ontology development framework .4
4.3 Governance structures in ontology development and maintenance in alignment with
the ISO standards on IDMP .5
5 Use cases for an IDMP ontology. 6
5.1 Practical applications of IDMP ontology in regulatory frameworks .6
5.2 Identifying substances, pharmaceutical and medicinal products unambiguously .6
5.2.1 Use case 1 (UC1): Ensuring unambiguous identification of substances .6
5.2.2 Area of focus .7
5.2.3 UC1 description .7
5.2.4 Stakeholders, actors, interfaces .8
5.2.5 UC1 usage scenarios .8
5.3 Enabling interoperability between regulatory, manufacturing and healthcare domains .14
5.3.1 Use case 2 (UC2): overview . .14
5.3.2 Scope of UC2 .14
5.3.3 Stakeholders and actors . . 15
5.3.4 UC2 description . 15
5.3.5 Usage scenarios .18
5.3.6 Competency questions .19
5.4 Jurisdiction-agnostic medicinal products . 23
5.4.1 Use case overview . 23
5.4.2 Competency question (CQ) .24
5.5 Ensuring interoperability between regulatory, clinical development and healthcare
domains . .24
5.5.1 Use case overview .24
5.5.2 Linking therapeutic indication(s) to their medicinal products and associated
active substances: competency question . 25
5.6 Ensuring global interoperability for the detection of supply chain and drug shortages . 25
Annex A (informative) Examples of regional implementation .26
Bibliography .30

iii
ISO/DTS 21405:2025(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee
has been established has the right to be represented on that committee. International organizations,
governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO’s adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 215, Health informatics, in collaboration with
the European Committee for Standardization (CEN) Technical Committee CEN/TC 251, Health informatics, in
accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

iv
ISO/DTS 21405:2025(en)
Introduction
ISO 11615, ISO/TS 20443, ISO/TS 20451, ISO 11238, ISO/TS 19844, ISO 11239, ISO/TS 20440, and ISO 11240
are the ISO Standards and Technical Specifications which together provide the basis for the unique
identification of medicinal products (IDMP). These documents present an opportunity to create global data
interoperability for the unambiguous identification of medicinal products. However, implementations of
IDMP by various IDMP stakeholders across jurisdictional domains are not fully standardized or harmonized
and risk inconsistency of interpretation. A uniform approach is needed so that the envisioned benefits from
IDMP in drug safety, innovation, regulatory, and other areas can be fully realized.
This document proposes an ontological framework for IDMP to provide the overarching structure and
principles for organizing knowledge within the domain of unambiguous identification of medicinal
products. Such a framework can provide the necessary foundation for global data interoperability through
a set of concepts, formal definitions and other metadata, their properties, the relations between them, and
the logical expressions that disambiguate them. This IDMP ontological framework complements the existing
conceptual models defined in the ISO documents on IDMP.
An IDMP ontology instantiates the principles represented in the IDMP ontological framework through
a particular representation of this domain knowledge. Furthermore, an IDMP ontology provides formal
semantic definitions for IDMP concepts that allow auto-classification and linkage of IDMP data and detection
of data issues and decrease the potential for misinterpretations and incorrect reporting.
The modelling of IDMP standards in the form of an open ontology requires the application of a set of rigorous
processes combined with various technology components, which together form a collaborative ontology
development structure. This framework includes feedback loops to IDMP stakeholders and interested
parties, including regulators and standards development organizations (SDOs), to ensure the relevant level
of governance for the accurate representation of IDMP standards representation.
Furthermore, considering the current global initiatives towards data interoperability, this ontological
framework aims to leverage and support those initiatives towards the common goal of cross-jurisdictional
unambiguous identification of medicinal products.

v
FINAL DRAFT Technical Specification ISO/DTS 21405:2025(en)
Health informatics — Identification of medicinal products
— Methodology and framework for the development and
representation of IDMP ontology
1 Scope
This document describes a standardized methodology and framework for the development and
representation of an ontology that supports a global, open-source approach to implementing the ISO
standards on the identification of medicinal products (IDMP) (ISO 11615, ISO/TS 20443, ISO/TS 20451,
ISO 11238; ISO/TS 19844, ISO 11239, ISO/TS 20440, and ISO 11240). Realization of the full potential of
IDMP requires fully self-describing data. For this purpose, this document describes a methodology and
framework that complements the existing conceptual and logical models in the ISO documents on IDMP with
an IDMP ontology that enables deep, semantic interoperability based on findable, accessible, interoperable
and reusable (FAIR) data principles. This methodology and framework enhance the usage of the IDMP data
model as the foundation of medicinal product identification and will ultimately enable collaboration towards
drug safety and overall operational efficiency.
This document also describes a methodology for the agile adaptation of the ISO documents on IDMP in
connection with cross-jurisdictional IDMP-related legislation and initiatives. This document is intended to
be complementary to and independent from formal regulatory guidance. Thus, it enables cross-jurisdictional
consistency and supports stakeholders in their regional implementations of IDMP standards. This document
does not mandate any specific ontology as an implementation tool, nor is it an instructional guideline on
how to build ontologies, which is out of scope of this document.
This document includes key use cases described in the ISO documents on IDMP ISO 11615, ISO 11238 and
ISO/TS 19844, as well as further use cases arising from the comprehensive deployment of the ISO documents
on IDMP via an ontological framework. Thus, an ontology that represents the IDMP standards aims to cover
the complete collection of ISO standards on IDMP regarding key interoperability issues that implementing
stakeholders are facing.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
axiom
statement that is taken to be true, to serve as a premise for further reasoning
Note 1 to entry: Axioms may be formulated as natural language sentences or as formulae in a formal language. In the
Web Ontology Language (OWL) community, ‘Axiom’ is used to refer to statements that say what is true in the domain
that are ‘basic’ in the sense that they are not inferred from other statements.
[SOURCE: ISO/IEC 21838-1:2021, 3.9]

ISO/DTS 21405:2025(en)
3.2
chemical class
a grouping that relates chemicals by similar features.
Note 1 to entry: Chemicals can be classified by their structure (e.g. hydrocarbons), uses (e.g. pesticides), physical
properties [e.g. volatile organic compounds (VOCs)], radiological properties (e.g. radioactive materials), or other
factors.
Note 2 to entry: Adapted from Reference [18].
3.3
competency question
query that represents requirements in the form of questions
Note 1 to entry: An ontology (3.12) is required to answer competency questions.
Note 2 to entry: Adapted from Reference [19].
3.4
concept
unit of knowledge created by a unique combination of characteristics
[SOURCE: ISO 1087:2019, 3.2.7, modified — Notes to entry removed.]
3.5
conceptual model
description of common concepts (3.4) and their relationships, particularly in order to facilitate exchange of
information between parties within a specific domain of healthcare
[SOURCE: ISO/TS 18864:2017, 3.6]
3.6
functional group
in organic chemistry, any substituent or moiety in a molecule that causes the molecule’s characteristic
chemical reactions
Note 1 to entry: Adapted from Reference [20].
3.7
international nonproprietary name
INN
generic name
globally recognised unique name of pharmaceutical substance and active pharmaceutical ingredient
Note 1 to entry: International nonproprietary name (INN) facilitates the identification of pharmaceutical substances
or active pharmaceutical ingredients.
Note 2 to entry: In principle, INNs are selected only for the active moiety of the molecule, which is usually the base,
acid, or alcohol.
Note 3 to entry: Each INN is public property.
Note 4 to entry: Adapted from Reference [21].
3.8
international nonproprietary name modified
INNM
extension of international nonproprietary name (INN) (3.7) including inactive moiety of the molecule
EXAMPLE While oxacillin and ibufenac are INNs, oxacillin sodium and ibufenac sodium are INNMs designating
their salts in the name.
Note 1 to entry: Adapted from Reference [21].

ISO/DTS 21405:2025(en)
3.9
knowledge graph
graph representation of structured knowledge on concepts (3.4) and relationships between them
Note 1 to entry: A knowledge graph can comprise an ontology (3.12) and data related to the ontology.
Note 2 to entry: A knowledge graph can be represented as a collection of triples, with each triple (head, tail, relation)
denoting the fact that relation exists between head entity and tail entity.
[SOURCE: ISO/IEC 5392:2024, 3.14]
3.10
logical model
information model that specifies the structures and relationships between data elements but is independent
of any particular technology or implementation environment
[SOURCE: ISO 13972:2022, 3.1.8, modified — The preferred term “logical information model” was removed.]
3.11
metadata
record containing a description of a resource
[SOURCE: ISO 24622-1:2015, 2.10, modified — The preferred terms “metadata record” and “metadata
description” were removed.]
3.12
ontology
formal, explicit specification of a shared conceptualization
Note 1 to entry: An ontology typically includes definitions of concepts (3.4) and specified relationships between them,
set out in a formal way so that a machine can use them for reasoning.
Note 2 to entry: An ontology provides a comprehensive description of terminology, concepts, and nomenclature;
outlines the relationships among and between concepts and individuals; and includes statements that clarify concepts,
refine definitions, and specify relationships (such as constraints, restrictions, and regular expressions) relevant to a
[22]
particular domain or area of interest.
Note 3 to entry: Conceptualization is meant to denote the objects, concepts, and other entities that are presumed to
[23]
exist in some area of interest and the relationships that hold them.
[SOURCE: ISO 25964-2:2013, 3.57 modified — Note 1 to entry was changed, Notes 2 and 3 were added.]
3.13
provenance
information on the place and time of origin, derivation or generation of a dataset, proof of authenticity of the
dataset, or a record of past and present ownership of the dataset
[SOURCE: ISO/IEC 11179-33:2023, 3.11]
3.14
regression test
test type used following modifications to a test item or to its operational environment, to identify whether
regression failures occur
Note 1 to entry: Adapted from ISO/IEC/IEEE 29119-1:2022, 3.64.
3.15
use case
description of behavioural requirements of a system and its interaction with a user
Note 1 to entry: A use case describes the users’ goal and the requirements including the sequence of interactions
between users and the system.
[SOURCE: ISO/IEC/IEEE 26515:2018, 3.15]

ISO/DTS 21405:2025(en)
3.16
user story
simple narrative illustrating a user requirement from the perspective of a persona
[SOURCE: ISO/IEC/IEEE 26515:2018, 3.16]
3.17
vocabulary
terminological dictionary that contains designations and definitions from one or more domains or subjects
[SOURCE: ISO 1087:2019, 3.7.5, modified — Note 1 to entry was removed.]
4 Benefits of an ontological approach for IDMP
4.1 General
The provision of a shared vocabulary and a common understanding of concepts and relationships (conceptual
model) enables information to be shared and reused across different applications and domains. In a logical
model, relationships and data structures are further specified. Ontologies can facilitate interoperability even
further by providing a formal framework for querying, reasoning and inference, which enables automated
processing of information based on logical rules and constraints. Figure 1 shows the differences between
glossary, conceptual model, logical model and ontology, demonstrating an increased semantic enrichment at
each upper level.
Figure 1 — Differences in semantic richness between vocabulary, conceptual model, logical model,
and ontology
4.2 Recommended methodology for collaborative IDMP ontology development – Ontology
governance in a collaborative ontology development framework
Governance in the context of ontology-related work provides a set of rules, policies, and procedures for
managing the ontology development process, and is thus critical to the success of collaborative ontology
development. It ensures that all involved stakeholders work effectively towards common goals, and that the
resulting ontology is consistent, accurate, and useful. The framework for overall development of an IDMP

ISO/DTS 21405:2025(en)
ontology is the set of ISO standards on IDMP and related standards on their implementation. Extensions to
that framework supporting the development of the IDMP ontology described herein include:
[24]
— development guidelines and policies ;
[25]
— common, standardized modelling patterns ;
— methods for mapping the ontology to reference as well as internal pharma company data to prove the
[26]
efficacy and interoperability of the ontology ;
[27]
— sample data and queries for regression testing ;
— a continuous integration (CI) and continuous delivery (CD) environment supporting global development
[28]
collaboration .
The methodology supported herein adheres to the policies and guidelines, follows best practices in ontology
engineering, including development of key use cases and scoping competency questions as described in
Clause 5, and extends best practices using this framework for collaborative development, evolution, and
maintenance.
Important governance requirements in collaborative ontology development, which can also be beneficial in
ensuring the wide adoption of ISO standards on IDMP, include the following.
— Standardization: Ontology governance ensures that all ontology developers follow the same standards,
naming conventions, and modelling methodologies, making it easier to integrate and share ontologies
across different systems and other ontologies.
— Quality Assurance: Ontology governance provides guidelines for verifying the accuracy and completeness
of the ontology, ensuring that it meets the needs of its intended users, and that it is free of errors and
inconsistencies. It also provides a feedback mechanism that is required for continuous improvement and
for any incident requiring immediate attention.
— Collaboration: Ontology governance encourages collaboration and communication among ontology
developers, helping them to identify and resolve issues, share knowledge, and ensure that the ontology
is aligned with the needs of its stakeholders and business area.
— Management: Ontology governance provides a framework for managing the development and
maintenance of the ontology, including versioning, change management, and release management.
— Sustainability: Ontology governance helps to ensure the sustainability of the ontology by providing
guidelines for ongoing maintenance and updates and ensuring that the ontology remains relevant and
useful over time.
4.3 Governance structures in ontology development and maintenance in alignment with
the ISO standards on IDMP
Decisions regarding ontology modelling and adaptations can be made by an executive board consisting of
standards development organizations, e.g. ISO, HL7 FHIR, regulatory agencies, pharma representatives and
further stakeholders, to ensure their alignment. These changes can be related to e.g. emerging requirements,
IDMP model clarification, controlled vocabularies, cardinalities and other constraints, and implementation
lessons learned, and include updates due to results of the systematic reviews of each of the ISO standards on
IDMP. These are implemented and documented in the IDMP ontology in an agile manner. In addition, end-to-
end testing for quality assurance and regression tests are performed throughout the ontology development
process, to identify any errors in syntax, logic, potential performance issues, missing content required by
development policies and guidelines, and other quality-related issues.

ISO/DTS 21405:2025(en)
5 Use cases for an IDMP ontology
5.1 Practical applications of IDMP ontology in regulatory frameworks
The overarching goals of integrating and managing product data within an organizational framework
encompass a variety of critical business questions that need answers to ensure operational efficiency and
compliance. The unambiguous identification of medicinal products is vital for gaining and maintaining
oversight of the various identifiers involved in the manufacturing and regulatory processes. This clear
identification and linkage of product information entities to their medicinal products and manufactured
items are crucial for streamlining manufacturing operations, increasing quality and responsiveness, and
ensuring a smooth supply chain, and promoting patient safety at the end of the supply chain.
Furthermore, establishing a robust association between the internal and external identifiers required for
product data submission is essential for regulatory compliance and efficiency. By simplifying product data
management processes, the goal is to increase overall performance and reduce the occurrence of errors,
which can have far-reaching implications for both safety and compliance. Improving data best practices
is another key objective, ensuring that the organization’s data management strategies are aligned with
industry standards and across the industry domain. This includes enabling an automation strategy to reduce
manual interventions and increase reliability across all aspects of product data management.
An IDMP ontology also aims to unlock advanced analytics potential, particularly in the realm of
pharmacovigilance, where the ability to analyse data effectively can lead to significant improvements in
signal detection, and consequently patient safety and product quality. The use of an IDMP ontology as a
data fabric will enhance multi use case support, increasing the high precision required in the representation
of scientific knowledge. Using its natural property of modularity, this ontology will support different
pharmaceutical industry use cases and processes ensuing a constant alignment with IDMP specifications.
The use of an IDMP ontology should be thoroughly tested end-to-end with publicly available data as well
as internal pharma company data to prove its efficacy. The ISO standards on IDMP being revised on a
regular basis, there is a need to ensure a continuous testing with any further revisions for regular checks on
backwards compatibility.
With regards to some key quality assurance criteria, the creation of an IDMP ontology requires the
establishment of internal, organization-specific set of testing to ensure each new version of the ISO
standards on IDMP results in a smooth integration and careful assessment of the potential impacts. This
can be achieved by setting-up a regression testing, a testing regarding syntactic pitfalls, to maintain
backwards compatibility by analysing the impact of the changes. The setting of acceptance criteria for
assessing the quality and completeness of the ontology and ensuring it meets regulatory requirements and
interoperability standards will depend on the level of criticality of the IDMP ontology and the systems using
it (e.g. GxP, non-GxP). This way the quality of the ontology is ensured and sustainable for the organization,
ensuring a continuous support of the evolving use cases.
Exemplary use cases specific to the application of an IDMP ontology are described in 5.2, 5.3, 5.4, 5.5, and 5.6.
5.2 Identifying substances, pharmaceutical and medicinal products unambiguously
5.2.1 Use case 1 (UC1): Ensuring unambiguous identification of substances
For the representation of the ISO standards on IDMP in an ontological format, an important use case to
consider is that of the unambiguous identification of substances. It emphasizes the importance of establishing
a robust, interoperable framework that enables the consistent and accurate classification of substances in
medicinal products. An IDMP ontology facilitates a unified structure for medicinal product information,
thus supporting regulatory compliance and enhancing the efficiency and reliability of data-sharing across
borders and contributing to improved patient safety.

ISO/DTS 21405:2025(en)
5.2.2 Area of focus
The area of focus of UC1 for unambiguous substance identification is as follows:
— ISO 11238
— Entities and relationships defined in the standard, e.g. substance relationship (parent relation),
active moiety.
— Substance information, e.g. INN/INNM.
— ISO 11615
— Relations between Substance, Investigational and Authorized Medicinal Product (separate use cases).
— A substance comprises an ingredient.
— An ingredient is used in a pharmaceutical product.
— A pharmaceutical product is a component of a medicinal product.
— A substance comprises an ingredient.
— An ingredient is included in a manufactured item.
— A manufactured item is contained in a packaged item.
— A packaged item constitutes a packaged medicinal product.
— A packaged medicinal product is an instance of a medicinal product.
— Product cross-reference between Investigational and Authorized medicinal product.
— Predefined instance datasets including example substances, e.g. amlodipine.
5.2.3 UC1 description
The objective of this use case is to enable the maintenance of substance data and link it with both external
and internal standards. For instance, it is essential to distinguish between the active form and the salt or
solvate form of a substance or between the whole plant and its extract in a herbal. This will also enable the
ability to track changes across all relevant domains without manual intervention. The proper identification
of the substance and its related entities and identifiers allows a simple alignment between systems in
multiple departments, such as clinical trial management systems (CTMS), reference and master data
management [(R)MDM] systems, enterprise resources planning [ERP (e.g. SAP)], and regulatory information
management (RIM) systems, linking to the “real substance” concept, and establishing a unique identifier
(ID) for substance specifications.
Currently, the process is bogged down by manual efforts and extensive knowledge required to cross-
reference external databases with internal MDM and golden source systems. This results in repetitive,
siloed, manual data curation across various levels and systems, alongside manual report generation to
bridge information gaps, which is not only time-consuming but also prone to errors.
The envisioned gains and benefits of this use case within an IDMP ontology are multifaceted. Aligning data
[29]
with a central knowledge graph (KG), e.g. the Global Substance Registration System (GSRS), ensures
data quality and eliminates the need for individual manual efforts by defining relationship types based
on trusted external standards. It facilitates the integration of substance data with other companies, such
as during mergers or when using comparator substances in clinical trials. An ontology also allows for
the identification and documentation of hierarchical relationships between substances based on global
standards, identifies the source or reference of a substance name to support data maintenance and quality
assurance, and provides trust and transparency in the data linkage by making the origin of data visible
directly in the ontology (metadata and provenance).

ISO/DTS 21405:2025(en)
5.2.4 Stakeholders, actors, interfaces
In the complex landscape of pharmaceutical development and regulation, a diverse group of stakeholders are
pivotal in the unambiguous identification of substances. These include health authorities and data sources
across departments in pharma companies such as clinical; regulatory affairs; chemistry, manufacturing,
and controls (CMC); manufacturing; and pharmacovigilance. Key actors within these groups of stakeholders
such as master data managers and substance data stewards manage and oversee the integrity of substance
data in tandem with health authority reviewers to ensure compliance and safety across all stages of
pharmaceutical product development and management.
A network of systems and interfaces facilitates the management and exchange of substance data, including
global and regional substance registries such as the GSRS and the European Union Substance Registration
System (EU-SRS), alongside internal interfaces that bridge various departments like regulatory affairs
(RA), clinical, CMC, product supply, and the CTMS with the MDM system. Additionally, the World Health
Organization’s International Nonproprietary Names (WHO INN) system, anatomical therapeutic chemical
(ATC) coding system, various pharmacopoeias, and the Extended EudraVigilance Medicinal Product
Dictionary (xEVMPD) for encoding medicinal products are integral parts of this system landscape.
The data entities involved in this system landscape include active substances, excipients, adjuvants, and
the active moiety along with parent-child relations, which are critical for understanding the compositions
of pharmaceutical products and manufactured items. These entities also extend internally in pharma
research and development (R&D) to relations with projects, clinical studies, and other key components of
the pharmaceutical development process.
This domain-specific variability within the substance identification landscape poses challenges with data
accuracy for all involved stakeholders. To address these challenges, an IDMP ontology provides a structured
framework that supports harmonization of data definitions and relationships across relevant systems and
interfaces.
5.2.5 UC1 usage scenarios
5.2.5.1 Introduction to usage scenarios
Usage scenarios are specific, contextual examples that illustrate how the ontology will be utilized to
represent and organize knowledge within a given domain. They elaborate on the requirements outlined in
the description, including identification of requirements specific to an envisioned ontology or semantically
driven service or application. Scenarios are described as narrative, with supporting diagrams as appropriate.
In an agile process, every user story relevant to the use case should be included into one or more usage
scenarios.
5.2.5.2 Usage scenario 1: alignin the ingredient with its relevant role
As a data producer, the goal is to verify and correct all ingredient roles, to improve knowledge of the
ingredients in a formula and enhance data flow from product lifecycle management (PLM) system to the
regulatory information management (RIM) system.
Previously, the role of the ingredient was only determined as active or excipient. The IDMP standard
provides 4 roles – active, excipient, solvent or diluent, adjuvant. A verification of all the formulas by chemists
is needed to specify the role of each ingredient. A mass loading of data will need to be carried out.
5.2.5.3 Usage scenario 2: identifying all clinical studies in which medicinal products were
administered in region
a) As a member of a regulatory agency validation group, the goal is to assess and characterize new
substances and identify substance relationships and ensure data quality on an ongoing basis, based on
globally standardized substance data.
b) A regulatory agent requests information of a pharma company on all clinical studies in which any of the
company’s authorized medicinal products were administered to patients.

ISO/DTS 21405:2025(en)
c) The request is received by the CTMS data steward who queries registered products [including medicinal
product identifiers (MPIDs)] in a specific region.
d) The master data manager identifies all substances contained in the medicinal products registered in the
region. The substance data are aligned with external standards to avoid misunderstandings and ensure
patient safety.
e) The master data manager/substance data steward queries substances (including internal and external
IDs) contained in those clinical studies in the substance registry (based on, or sourced from GSRS,
in a system to be defined, ideally in a knowledge graph) where relevant internal and external data
alignments are defined in the IDMP-compatible way.
f) Based on this information, the master data manager collects relevant clinical studies data from internal
source systems and reports this information back to the health authority.
Figure 2 represents the process flow addressed in use case 1.
Figure 2 — Use case 1: ensuring unambiguous identification of substances
5.2.5.4 UC1 competency questions (CQ)
5.2.5.4.1 Introduction to competency questions
Competency questions (CQ) are natural language questions outlining and constraining the scope of
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knowledge represented in an ontology. They are questions that guide the selection of concepts, properties,
and relationships that the ontology needs to represent.
5.2.5.4.2 CQ1: Which substances have the common active moiety ?
A medicinal product can contain a mixture of substances each of which can have different roles (active,
excipient, solvent or diluent, adjuvant). It is the active ingredient in a medicinal product that is responsible
for the pharmacological activity of the medical product. In turn, the active moiety refers to the part of the
active ingredient which exerts the pharmacological action of the substance. This can consist of only a part of
or the entire molecule of the substance that is designated as the active ingredient. Since an active moiety can
exist in different forms in different substances, it is useful to be able to identify the possible substances that
have a certain common active moiety. This unambiguous identification of substances and active moieties
will enable a clear oversight of the involved substance identifiers.
EXAMPLE Amlodipine
— Question: What are all substances that have a common active moiety ?

ISO/DTS 21405:2025(en)
— Answer: Amlodipine besylate (+ internal substance ID)
— The dosage of the medicinal product is carried by the amount of alone, and not by the salt
.
— Answer: Amlodipine mesylate monohydrate (+ internal substance ID)
— In addition to the salt, the level of hydration is not to be considered for the same reason as above.
Figure 3 demonstrates the query pattern for CQ1.
Figure 3 — Query pattern diagram for CQ1 “Which substances have the common active moiety
?”
5.2.5.4.3 CQ2: What is the active moiety of ? Alternativ
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