FprCEN ISO/TS 19844-1

Health informatics - Identification of medicinal products (IDMP) - Part 1: Implementation of ISO 11238 (general) (ISO/DTS 19844-1:2026)

Medizinische Informatik - Identifikation von Arzneimitteln - Implementierungsleitfaden für ISO 11238 für Datenelemente und Strukturen zur eindeutigen Identifikation und zum Austausch von vorgeschriebenen Informationen zu Stoffen - Teil 1: ISO 11238 Implementierungsleitfaden für Datenelemente und Strukturen zur eindeutigen Identifikation und zum Austausch von vorgeschriebenen Informationen zu Stoffen (ISO/DTS 19844-1:2026

Informatique de santé - Identification des médicaments - Lignes directrices pour·la·mise·en·oeuvre de l'ISO 11238 relative aux éléments de données et structures pour l'identification unique et l'échange d'informations réglementées sur les substances - Partie 1: Titre manque (ISO/DTS 19844-1:2026)

Zdravstvena informatika - Identifikacija zdravil - 1. del: Izvajanje ISO 11238 (splošno) (ISO/DTS 19844-1:2026)

General Information

• Status: Not Published
• Publication Date: 23-Aug-2026
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: CEN/TC 251 - Medical informatics
• Current Stage: 5020 - Submission to Vote - Formal Approval
• Start Date: 26-Feb-2026
• Completion Date: 26-Feb-2026
• Ref Project: kSIST-TS FprCEN ISO/TS 19844-1:2026 - Health informatics - Identification of medicinal products (IDMP) - Part 1: Implementation of ISO 11238 (general) (ISO/DTS 19844-1:2026)

Relations

• Consolidated By: ISO/DTS 19844-1 - Health informatics — Identification of medicinal products (IDMP) — Part 1: Implementation of ISO 11238 (general)
• Effective Date: 12-Feb-2026
• Revises: CEN ISO/TS 19844:2017 - Health informatics - Identification of medicinal products - Implementation guidelines for data elements and structures for the unique identification and exchange of regulated information on substances (ISO/TS 19844:2016)
• Effective Date: 03-Jul-2024

Overview

FprCEN ISO/TS 19844-1:2026, titled "Health informatics - Identification of medicinal products (IDMP) - Part 1: Implementation of ISO 11238 (general)" is a technical specification developed by CEN in collaboration with ISO. This document provides detailed guidance for the implementation of ISO 11238, which is foundational to the global Identification of Medicinal Products (IDMP) standard suite. The primary focus is on the standardized definition, identification, and exchange of regulated information on substances used in medicinal products. By offering harmonized approaches and structured data requirements, FprCEN ISO/TS 19844-1 is essential for organizations and regulatory authorities involved in medicines regulation, pharmacovigilance, and healthcare information systems.

Key Topics

• Standardized Identification of Medicinal Product Substances

  • Defines scientific substance types (chemical, protein, nucleic acid, polymer, structurally diverse, and mixtures)
  • Mandates the assignment of unique, unambiguous substance identifiers (IDs) based on scientific properties

• Substance Data Requirements

  • Specifies required data elements for describing substances and specified substance groups
  • Outlines minimum and definitional data fields per substance type
  • Details on capturing information such as molecular structure, source, purity, and manufacturing processes

• Implementation Guidance for ISO 11238

  • Stepwise approach to defining substances and selecting unique identifiers
  • Differentiates between Substance-level and Specified Substance-level information according to regulatory needs
  • Highlights conditional, mandatory, and optional data elements relevant to regional and regulatory rules

• Support for Global Pharmaceutical Data Exchange

  • Enables structured, interoperable data to facilitate regulatory submissions, product registration, and ongoing pharmacovigilance
  • Guidance on leveraging public substance databases to minimize duplication and maximize data consistency

Applications

FprCEN ISO/TS 19844-1 has broad utility across the health informatics and pharmaceutical sectors:

• Regulatory Submissions and Product Registration

  • Standardizes medicinal product data submitted to regulatory agencies, ensuring clarity and comparability across jurisdictions

• Pharmacovigilance and Risk Management

  • Improves the ability to monitor, compare, and track substances in medicinal products for safety and efficacy analysis

• Data Harmonization and Interoperability

  • Supports integration with healthcare information technology (HIT) applications, laboratory systems, and electronic health records
  • Facilitates cross-border data communication and regulatory collaboration

• Vendor Solutions and IT System Development

  • Encourages the creation of "off-the-shelf" IT solutions and databases that support IDMP compliance
  • Reduces complexity for pharmaceutical companies and device manufacturers in developing compliant systems

• Public Health and Research

  • Assists non-commercial sponsors and research organizations in unambiguously defining substances for studies and evidence generation

Related Standards

• ISO 11238: Health informatics - Identification of medicinal products – Data elements and structures for the unique identification and exchange of regulated information on substances
• ISO 11615: Health informatics - Identification of medicinal products – Data elements and structures for the unique identification and exchange of regulated medicinal product information
• ISO 11616: Health informatics - Identification of medicinal products – Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information
• ISO 11239: Health informatics - Identification of medicinal products – Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging
• ISO 11240: Health informatics - Identification of medicinal products – Data elements and structures for the unique identification and exchange of units of measurement

Practical Value

• Enhances regulatory compliance across multiple jurisdictions by providing a unified structure for product information submission
• Streamlines data exchange between industry stakeholders, regulators, and healthcare entities
• Reduces errors and inconsistencies in substance identification, promoting patient safety and effective product lifecycle management
• Facilitates global harmonization of pharmaceutical data, supporting efficient regulatory review and public health initiatives

By implementing FprCEN ISO/TS 19844-1, organizations ensure alignment with internationally recognized standards for the identification and description of medicinal product substances, positioning themselves for long-term success in a highly regulated and interconnected global healthcare environment.

Standards Content (Sample)

SLOVENSKI STANDARD
01-april-2026
Zdravstvena informatika - Identifikacija zdravil - 1. del: Izvajanje ISO 11238
(splošno) (ISO/DTS 19844-1:2026)
Health informatics - Identification of medicinal products (IDMP) - Part 1: Implementation
of ISO 11238 (general) (ISO/DTS 19844-1:2026)
Medizinische Informatik - Identifikation von Arzneimitteln - Implementierungsleitfaden für
ISO 11238 für Datenelemente und Strukturen zur eindeutigen Identifikation und zum
Austausch von vorgeschriebenen Informationen zu Stoffen - Teil 1: ISO 11238
Implementierungsleitfaden für Datenelemente und Strukturen zur eindeutigen
Identifikation und zum Austausch von vorgeschriebenen Informationen zu Stoffen
(ISO/DTS 19844-1:2026)
Informatique de santé — Identification des médicaments — Lignes directrices
pour·la·mise·en·oeuvre de l'ISO 11238 relative aux éléments de données et structures
pour l'identification unique et l'échange d'informations réglementées sur les substances
— Partie 1: Titre manque (ISO/DTS 19844-1:2026)
Ta slovenski standard je istoveten z: FprCEN ISO/TS 19844-1
ICS:
11.120.10 Zdravila Medicaments
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 19844-1
ISO/TC 215
Health informatics — Identification
Secretariat: ANSI
of medicinal products (IDMP) —
Voting begins on:
2026-02-26
Part 1:
Implementation of ISO 11238
Voting terminates on:
2026-05-21
(general)
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 19844-1:2026(en) © ISO 2026

FINAL DRAFT
ISO/DTS 19844-1:2026(en)
Technical
Specification
ISO/DTS 19844-1
ISO/TC 215
Health informatics — Identification
Secretariat: ANSI
of medicinal products (IDMP) —
Voting begins on:
Part 1:
Implementation of ISO 11238
Voting terminates on:
(general)
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 2026
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.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
ISO/DTS 19844-1:2026(en) © ISO 2026

ii
ISO/DTS 19844-1:2026(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 Symbols and abbreviated terms. 2
5 Substance . 2
5.1 General .2
5.2 Defining substances .5
5.2.1 Defining a substance .5
5.2.2 Substance type .6
5.2.3 Substance ID .9
5.2.4 Alternative definition (optional) .10
6 Choosing a Substance ID .13
6.1 General . 13
6.2 Requesting a Substance ID and providing information . 13
7 Substance definitional fields and substance minimum fields . 14
7.1 Overview .14
7.1.1 General .14
7.1.2 Substance signature/minimum information .14
7.1.3 Substance definitional information .14
7.2 Minimum fields per substance type . 15
7.3 Definitional fields per substance type .18
7.3.1 Chemicals .18
7.3.2 Protein .18
7.3.3 Nucleic acid . 22
7.3.4 Polymer . 23
7.3.5 Structurally diverse . 25
7.3.6 Mixture .27
7.3.7 Specified Substance Group 1 . 29
Annex A (informative) Advanced Therapies and Advanced Vaccines (genes, modified viruses,
cells and tissues as Substances) .31
Bibliography .35

iii
ISO/DTS 19844-1:2026(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 document 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).
This first edition of ISO/TS 19844-1, together with ISO/TS 19844-2, ISO/TS 19844-3, ISO/TS 19844-4,
ISO/TS 19844-5, ISO/TS 19844-6, ISO/TS 19844-7, ISO/TS 19844-8, ISO/TS 19844-9, ISO/TS 19844-10,
ISO/TS 19844-11 and ISO/TS 19844-12, cancels and replaces ISO/TS 19844:2018, which has been technically
revised.
The main changes compared to the previous edition are as follows:
— split of 19844 into a series of documents;
— addition of “minimum fields” and “definitional fields” per substance information.
A list of all parts in the ISO/TS 19844 series can be found on the ISO website.
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 19844-1:2026(en)
Introduction
The objectives of the standards on the Identification of Medicinal Products (IDMP) are to support the
activities of medicines regulatory agencies worldwide by jurisdiction. These include a variety of regulatory
activities related to development, registration and life cycle management of medicinal products as well as
pharmacovigilance and risk management.
Due to the lack of a common and harmonized approach to define substances, regulators and pharmaceutical
industry are faced with the inability to:
— effectively exchange medicinal substance information in a structured and efficient way;
— ensure data consistency and evaluate/compare information across regions, which especially impairs
pharmacovigilance and compliance activities;
— develop consistent terminology for use throughout the healthcare community.
The ISO standards on IDMP, developed in response to a worldwide demand for guidance on the
implementation of internationally harmonized specifications for medicinal products, address the issues
outlined above by developing harmonized standards that build on the regulatory and technical processes
already established and to support the population and maintenance of existing systems/applications with
fully reliable regulatory medicinal product information.
Harmonized standards will stimulate vendors to develop “off-the-shelf” tools (that are interoperable due to
the standard itself). Harmonized standards will also help to maximize forward compatibility of data and
minimize the complexities of backward compatibility.
The ISO standards on IDMP consist of ISO International Standards and their supporting technical
[1]
specification. In addition to ISO 11238 , the other standards in this group are:
[2]
— ISO 11615 , Health informatics — Identification of medicinal products — Data elements and structures for
the unique identification and exchange of regulated medicinal product information;
[3]
— ISO 11616 , Health informatics — Identification of medicinal products — Data elements and structures for
the unique identification and exchange of regulated pharmaceutical product information;
[4]
— ISO 11239 , Health informatics — Identification of medicinal products — Data elements and structures
for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of
presentation, routes of administration and packaging;
[5]
— ISO 11240 , Health informatics — Identification of medicinal products — Data elements and structures
for the unique identification and exchange of units of measurement.
[1]
This document provides requirements and recommendations for implementing ISO 11238 . This
document is intended to assist stakeholders (including pharmaceutical companies, regulatory authorities
and non-commercial sponsors) in sharing information that allows substances to be defined unambiguously.
It also provides guidance to help identify the correct Substance ID from a public data source that provides
identified Substance and Specified Substance information. It is anticipated that an extensive list of substance
identifiers, as well as the definitional elements upon which the ID was based, will be provided. This document
is not intended to be a guide for a maintenance organization. The maintenance organization may also create
alternative methods to submit information consistent with the ISO model.
For the purposes of this document, all conformance corresponds to the necessary requirements to uniquely
[1] [6]
and unambiguously identify a substance. In the context of ISO 11238 and ISO/TS 19844 , conformance
is expressed based on the following terminology: Mandatory, Conditional and Optional.
— Mandatory: refers to data elements that are required and shall therefore be implemented.
— Conditional: refers to data elements that are subject to business rules and can become required by:
— data rules;
v
ISO/DTS 19844-1:2026(en)
— process rules;
— regional rules.
— Optional: refers to data elements that are informative but not definitional.
The description on whether a data element is conditional by data, by process or by regional rule is out of
scope of this document and will be defined within regional implementation guides. When there is no
information in the conformance table row (see Table 1) (e.g. information on business rule is not provided),
users need to refer to the regional implementation guide.
Regional implementation may also dictate that clauses tagged conditional or optional in the ISO standard
are mandatory elements on regional requirements. Therefore, if a subclause is identified as ‘optional’ but
is implemented in a specific region, conformance on data elements described within that subclause is
applicable.
A systematic approach is being followed to describe classes and elements. Table 1 is an example table for
class and elements description.
Table 1 — Example table for class and element description
User guidance
Example(s)
Conformance
Data type
Values allowed
Business rule(s)
vi
FINAL DRAFT Technical Specification ISO/DTS 19844-1:2026(en)
Health informatics — Identification of medicinal products
(IDMP) —
Part 1:
Implementation of ISO 11238 (general)
1 Scope
[1]
This document provides requirements and recommendations for the implementation of ISO 11238 . This
document defines substances based on their scientific identity (i.e. what they are) rather than on their use or
method of production.
[1]
ISO 11238 provides the conceptual framework for defining Substances and Specified Substances and for
[1]
assigning unique identifiers in the context of the ISO standards on IDMP. ISO 11238 describes general
concepts for defining and distinguishing substances and a high-level model for the structuring of information
for substances. This document provides detailed explanations of each type or grouping of substance
[1]
information, an element-by-element description for the implementation of ISO 11238 , and examples for a
variety of Substances and Specified Substances.
This document covers:
— the data elements necessary for describing Substances and Specified Substances Groups 1 to 4;
— the data elements necessary for the unique definition of Substances and Specified Substances Groups 1;
[1]
— the logical use of data elements as defined in ISO 11238 .
This document does not cover:
— business processes for data management;
— implementation of a specific data information system (e.g. a relational database schema);
— normative messaging standards for substances;
— the maintenance of controlled vocabularies;
— the specific global identifier system to be used;
— nomenclature standards for substances.
This document does not cover Substances and Specified Substances Groups 1 to 4 business rules for:
— determining necessary data elements;
[1]
— distinguishing and defining material types according to ISO 11238 ;
— triggering the assignment of identifiers.
Due to their inherent complexity, the specific case of Advanceed Therapies will be addresses in future
versions of this document. An overview of Advanceed Therapies is available in Annex A.

ISO/DTS 19844-1:2026(en)
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 11238, Health informatics — Identification of medicinal products — Data elements and structures for the
unique identification and exchange of regulated information on substances
3 Terms and definitions
No terms and definitions are listed in this document.
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/
4 Symbols and abbreviated terms
[1] [6]
NOTE Only general abbreviations are listed. They are used either within ISO 11238 or ISO/TS 19844 since
these documents are regarded as inseparable.
1)
CAS Chemical Abstracts Service number
INN International Nonproprietary Name [also consider as rINN (recommended International
2)
Nonproprietary Name) or pINN (proposed International Nonproprietary Name)]
3)
JAN Japanese Accepted Name
4)
USAN United States Adopted Name
5 Substance
5.1 General
All medicinal products consist of substances; these substances can be active ingredients, excipients,
or packaging materials. The substances shall be described in accordance with ISO 11238. There are
[1]
two fundamental levels of information described in ISO 11238 , a “Substance level" and a “Specified
Substance level”. Both levels are included in the more generic concept of an ingredient. At the Substance
level, substances are defined based on inherent attributes rather than use or method of manufacture. At the
Specified Substance level, four separate groups of elements provide additional information.
In order to define or distinguish material either at a Substance or Specified Substance level, a number of
attributes should be taken into consideration:
— For chemicals, the molecular structure is captured at the Substance level.
— For proteins, the amino acid sequence, sites and type of glycosylation, and the presence of modifications
and position of disulfide bonds are captured at the Substance level.
1) https://www.cas.org/about-us
2) http://www.who.int/medicines/services/inn/en/
3) https://moldb.nihs.go.jp/jan/En
4) https://www.ama-assn.org/about/united-states-adopted-names-council

ISO/DTS 19844-1:2026(en)
— For nucleic acids, the sequence, type of sugar and linkage and modifications are captured at the Substance
level.
— For other polymers, the monomers used to synthesize the polymer, the structural repeat units, the
molecular weight and/or a property related to molecular weight (e.g. viscosity), the source of naturally
derived polymers and any modifications that irreversibly alter the molecular structure are captured at
the Substance level.
— For structurally diverse material, taxonomic, anatomical and fractionation information, properties
related to the underlying molecular structure of the material, and modifications that alter the underlying
molecular structure are captured at the Substance level.
— A Mixture consists of a simple combination of Single Substances that are either isolated together or
are the result of the same synthetic process. This applies also to a homologous group of structurally
diverse single substances used to prepare an allergen extract. The biological source of the mixture is
also captured where relevant at the substance level. Proportions are not captured at the substance level.
It should be noted that a mixture description should only include the substances that are generally or
consistently present in the material. This excludes impurities and degradants.
Other attributes will be specific to the Specified Substance levels:
— constituent substances in a multi-substance material;
— proportions of constituent substances in a multi-substance material;
— physical state;
— grade or purity of material.
There are four groups of elements that are used to further define and specify Substances. Specified
Substances are always composed of at least one substance.
Specified Substance Group 1 (SSG1) is typically used to define:
— multi-substance materials consisting of multiple substances, which are not defined as mixture;
— defining information regarding homeopathic, plasma derived, vaccines substances, herbal and allergenic
extracts;
— physical state, including polymorphic forms;
— detailed glycosylation information.
Specified Substance Group 2 (SSG2) is typically used to define:
— manufacturer, manufacturing process and critical process version number. In some cases extended
manufacturing information are used to provide information regarding herbal and allergenic extracts when
multiple extraction methods with different solvent compositions are used or a stepwise manufacturing
process is in place describing an extraction method followed by a general modification process of the
extract, e.g. modified allergen extract, modified vaccines by multiple modification processes.
Specified Substance Group 3 (SSG3) is typically used to define:
— grade or level of purity (Pharmacopoeial Specifications) and in-house specification used to cover a set of
specifications of all approved manufacturers for the substance.
Specified Substance Group 4 is typically used to define:
— detailed specification information including analytical information to be used in tests;
— detailed manufacturing information.

ISO/DTS 19844-1:2026(en)
Figure 1 — High-level Substance-Specified Substance information model
EXAMPLE In Figure 1, the Substance class is parent of the classes Specified Substance Group 1 (SSG1), Specified
Substance Group 2 (SSG2) and Specified Substance Group 3 (SSG3). Similarly, SSG1 is a parent of SSG2 and SSG3. For
Triamcinolone acetonide, Figure 2 shows the relationships of Substance and Specified Substance Groups.
Figure 2 — Parent Substance and Specified Substances Groups relationships of Triamcinolone
acetonide
ISO/DTS 19844-1:2026(en)
5.2 Defining substances
5.2.1 Defining a substance
A substance is any matter that has discrete existence, whose origin can be biological, mineral or chemical.
Substances can be single well-defined chemical entities containing a definite molecular structure, synthetic
(e.g. isomeric mixtures) or naturally-occurring (e.g. conjugated oestrogens) mixtures of chemicals, or
materials derived from plants, animals, micro-organisms or inorganic matrices that are not definable by
a single or limited number of molecular structures. Substances can contain active moieties, salts, solvates,
(non)-stoichiometric complexes or mixtures of compounds that are isolated or synthesised/obtained or
produced in a process together. Materials that are combined from multiple sources to form a product are not
considered to be substances.
A substance is generally defined by what it is, and not by how it is made or used. Substance definitions are
typically based on the immutable properties of a given material. These properties include the molecular
structure, or structures of a given material, taxonomic, anatomical or fractionation information for material
that cannot be represented by molecular structures. Purity, physical form, and method of production are
typically not considered when defining substances.
In addition to defining information, there is also information that is essential to validate the defining
information; this additional information should be submitted if available. Validation can be performed based
on relevant provided documents (e.g. regulatory dossier) or information available in recognised source (e.g.
pharmacopoeias).
[1]
The primary goal of ISO 11238 is to define all substances present in regulated products unambiguously.
Once a substance has been defined, a unique identifier will be assigned that is permanently associated with
that substance. This document describes the necessary information for this registration process. Reference
information, names, codes and IDs that can be associated with a substance are also described. This document
is not comprehensive in regards to reference and definitional information. Other substance attributes can
be associated for both reference and definitional information as new scientific standards or information
becomes available.
Substances that are mixed together to form a product, even if there are physical interactions between the
Substances, will be described as a Specified Substance or a product.
A high level overview of the information model for the Substance class is provided with Figure 3.
EXAMPLE 1 FD&C Blue No. 1 Aluminium Lake is not defined as a mixture substance but rather as two separate
substances FD&C Blue No. 1 and aluminium oxide. Also, simethicone is not a substance because it contains two
substances, namely dimethicone and silicon dioxide. These materials would be described as Group 1 Specified
Substances.
Conversely, if new covalent bonds and/or simple salts or solvates are formed, separate Substance IDs for each
molecular entity are assigned.
EXAMPLE 2 Fluticasone propionate would have a separate ID from fluticasone; atorvastatin calcium trihydrate
would have a separate ID from atorvastatin calcium anhydrous.
Differences at the Specified Substance level trigger a new Specified Substance ID.
EXAMPLE 3 Insulin Human Crystalline and Insulin Human Amorphous have different Specified Substances Group 1
IDs and map to the substance Human Insulin.

ISO/DTS 19844-1:2026(en)
Figure 3 — High-level information model for substances
5.2.2 Substance type
At the basic level, all material present in medicinal products will either be described as a Substance and/or
a Specified Substance Group 1.
Additional information, such as manufacturer and grade and manufacturing information on a given material
will be associated with Specified Substance Groups 2 to 4.
Substances shall be defined using one of the five types of single substances or a mixture. Mixtures consist
of a combination of related single substances where the source material and essential properties are also
captured but proportions are not.
Mixtures also describe extracts of homologous groups of substances and in this case the proportions of the
multi-substance starting materials are captured.
For the purposes of definition, all single substances are of one of the following types:
— (simple) chemical;
— protein;
— nucleic acid;
— polymer;
— structurally diverse.
Each of these different types of single substances has distinct elements essential for substance definition.

ISO/DTS 19844-1:2026(en)
Some special materials can appear to have elements from multiple types of single substances, e.g. PEGylated
proteins, drugs covalently linked to polymeric matrices or proteins, to fully define the substance. Each of
these complex materials will be described according to a single substance type, although it is possible for the
same material to be described by using two substance types, of which only one is the primary/predominant
one, with the other related to it as an alternative definition. For more details on this specific relationship,
see 5.2.4.
Most other polymers will be described as single substances with the definition based on the structural
repeat unit and a representation of the average molecular weight of the polymer as well as the biological
source for biopolymers or polymers derived from biological matrices.
[1]
Substances can also be a mixture of single substances. Mixture is defined in ISO 11238 as a type of
polydisperse substance that is a combination of single substances isolated together or produced in the same
synthetic process. Mixtures consist of a combination of related single substances where the source material
and essential properties could be captured with proportions at the Specified Substance Group 1 information
level, if applicable. For mixtures in which multiple related substances are isolated together from a single
source, the source will be a defining element.
EXAMPLE 1 Starches are typically a mixture of the two distinct polymers amylose and amylopectin. Corn, wheat,
potato and tapioca starches are all distinct substances distinguished by the source.
Additional information, such as manufacturer, grade, and manufacturing information on a given material
will be associated with Specified Substances Groups 2 to 4.
The first step in defining a material is to determine whether the material can be defined as a Single
Substance, a Mixture or a Specified Substance Group 1. A mixture is a substance that cannot be defined
using a single set of substance elements or structural representations. Racemic mixtures, most polymers
and structurally diverse substances, although inherently mixtures, can be defined using a single set of
elements and therefore are not described as mixtures. Material that contains multiple substances that
are not synthesised or isolated together and are not related or not derived from homologous groups of
substances will be described as Specified Substance Group 1. Specified Substance Group 1 also includes
crystalline polymorphs, substances in varied physical states along with the capture of additional properties
regarding sterility or the presence of endotoxin.
EXAMPLE 2 Specified Substance Group 1 include simethicone, adjuvanted vaccine antigens, isophane insulins and
additional herbal and allergenic extract information not captured at the Substance level.
EXAMPLE 3 Mixtures are substances such as Gentamicin sulfate, USP or Gentamicin sulfate, Ph.Eur. which consists
of mixtures of distinct but related individual aminoglycosides. In USP Gentamicin sulfate is described as a mixture of
Gentamicin C1A sulfate, Gentamicin C1 sulfate, and Gentamicin C2 sulfate. In Ph.Eur. it is described as a mixture of five
components, Gentamicin C1, C1a, C2, C2a, and C2b, which are typically isolated together from a bacterial culture.
At the substance level, all related substances typically present at a level greater than 1% shall be listed as
components of the mixture regardless of whether the substance is listed in a given pharmacopoeia.
Figure 4 shows a decision tree or process by which the type of substance is determined. Monodisperse
substances are substances that can be described as a single molecular entity. Polydisperse substances
are substances that typically have multiple molecular entities that are too numerous or too diverse to be
captured as a mixture (e.g. cells or tissues) or where the production of the substance inherently results in
polydispersity (e.g. polymers).

ISO/DTS 19844-1:2026(en)
Key
a
Multi-substance material: Multiple-Substances and/or Specified Substances of diverse origin.
b
Mixture: Type of polydisperse substance that is either a combination of single substances isolated together
or synthesised/obtained or produced in the same process or an extract of a homologous group of substances
(multi-substance starting material) resulting from the same synthetic process.
Figure 4 — Decision tree or process by which the type of substance is determined
Table 2 summarises the requirements for Substance type class.
Table 2 — Substance type
User guidance The Substance type shall be defined in accordance with the decision tree depicted in
Figure 4, supported by the supporting information in 5.2.2.
Example(s) Chemical, Protein, Nucleic acid, Polymer, Structurally Diverse, Mixture
Conformance MANDATORY
Data type CD
Values allowed Chemical, Protein, Nucleic Acid, Polymer, Structurally Diverse, Mixture, Specified Substance
Group 1, Specified Substance Group 2, Specified Substance Group 3
Business rules For each substance type, a qualification is possible, e.g. Structurally Diverse (Plasma-de-
rived), Structurally Diverse (Herbal Substance), Structurally Diverse (Herbal Drug), Struc-
turally Diverse (Allergen Substance), Polymer (Biopolymer), Protein (Recombinant), Protein
(Naturally-derived), Protein (Allergen, Naturally-derived), Chemical (Mineral, naturally oc-
curring substance), Mixture (Homologous Group of Allergen Source Material). In these cases,
the qualifier shall also be captured at the Substance Name Type attribute of the respective
[6]
ISO/TS 19844 clause, and shall always be coupled with the substance name.
For example:
Substance Type: Structurally Diverse
Substance Name Type: Plasma-derived
Substance Name: Human Albumin, Plasma-derived
In all these cases, a new ID shall be issued, that is, “Human Albumin, Plasma-derived” shall
have a distinct identifier from “Human Albumin, Recombinant”.

ISO/DTS 19844-1:2026(en)
5.2.3 Substance ID
Every substance shall be identified by a unique identifier (ID). An ID will be generated following the initial
submission of substance data. The ID shall be unique to each substance, non-semantic, non-chronological,
and of fixed length with an integrity check. Once an ID is assigned to a given physical or concept (see Note
below) material, the ID will not change. Changes or additions to defining information result in a new version
of the substance definition but would not result in a new Substance ID. Although an effort should always
be made to obtain the complete information prior to assignment, there will be instances where additional
definitional information on a given substance is transmitted after the assignment. When incorrect or
incomplete information are transmitted and used to define a substance, the existing substance information
will be updated but the unique Substance ID will not change.
EXAMPLE 1 Glucose, when a solid crystalline material, can exist with an alpha or beta pyranose structure in an
anhydrous state, or as a monohydrate with an alpha pyranose structure. In a medicinal product where a specific and
identified form of glucose exists, the ID specific to the structure is used. Glucose in a liquid or an amorphous solid state
uses the Substance ID that does not specify the specific form.
Both Substances and Specified Substances shall be identified with an ID. IDs will be released to the public if
the substance is in a licensed medicinal product. The IDs for substances in the investigational stage will only
be released if an official name exists or a company code is associated with defining information and is found
together in at least one single reference that is from a reputable source in the public domain (i.e. scientific
journal, presentations or posters at scientific conferences, company publication, patent or published patent
application, public databases such as STN from CAS). Substance IDs shall always be issued to the requester if
sufficient information is provided to unambiguously define the substance.
NOTE The notion of ‘conceptual material’ has been introduced by the EU and US jurisdictional implementations
(EU-SRS and GSRS databases) to allow the assignment of identifiers to lesser defined substances during e.g. their early
development stage where only very few information of the material is known. In addition, it is used to define further
aspects of a substance used in a medicinal product by using Specified Substance Group 1 elements. The status of a
[1]
conceptual material does not comply to the definitional information according to ISO 11238 for each substance
type. As soon the definitional information is provided in due time, the “conceptual material” can be upgraded to
[1]
“physical” material in compliance with the definitional rules of that substance type according to ISO 11238 and to
this document.
EXAMPLE 2 A description of a chemical substance by name without an unambiguous structure is a concept
material.
EXAMPLE 3 A description of a protein substance by name without a sequence is a concept material.
EXAMPLE 4 A description of a polymer substance by name without a structural repeat unit is a concept material.
EXAMPLE 5 A description of a nucleic acid substance by name without a sequence, sugar and linkage is a concept
material.
EXAMPLE 6 A description of a structurally diverse substance by name without proper taxonomic information and
without description of at least one major constituent, allergen.
EXAMPLE 7 A description of a mixture substance consisting of at least one of the above mentioned criteria is a
concept material.
Table 3 summarises the requirements for Substance ID class.

ISO/DTS 19844-1:2026(en)
Table 3 — Substance ID
User guidance ID to be used in all electronic submissions to identify a substance. Generated when sufficient
information is available to unambiguously define a substance. ID will be permanently asso-
ciated with a given substance and each substance at the substance level shall have one and
a
only one ID.
b
Example(s) UNII Code, EV-Code, Global Substance ID (DEVTYS543H)
Conformance MANDATORY
Data type II
Values allowed Value can be a code associated with a preferred term, or a specific type of data. If a code is
transmitted, the preferred term associated with that code should also be transmitted.
Business rule(s) All substances shall be identified by a single ID.
The conformance is mandatory in all cases. The only exception is at the time of the very first
c
submission where the ID is requested.
a
If a unique Substance ID has been assigned, this Substance ID is specified based on the Substance Name controlled vocabulary.
In the absence of a unique Substance ID, e.g. for the initial submission of the substance, this data element is not mandatory.
b
Global Substance ID corresponds to the ISO IDMP identifier of a Substance intended to be used globally.
c
The ID shall only be released to the public if the defining information is in the public domain or if a company that provides the
defining information requests public release or releases the code in public marketing materials. An ID will always be issued to an
organisation that requests an ID and supplies the
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