ISO/TR 23022:2018

TECHNICAL ISO/TR
REPORT 23022
First edition
2018-04
Traditional Chinese medicine —
Controlled vocabulary on Japanese
Kampo formulas and the indication
codes for the products
Médecine traditionnelle chinoise - Vocabulaire contrôlé relatif aux
formules Kampo japonaises et codes d'indication des produits
Reference number
©
ISO 2018
© ISO 2018
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ii © ISO 2018 – All rights reserved

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Abbreviated terms . 5
5 Conformance . 6
6 Coding system . 6
Annex A (informative) Controlled vocabulary of Japanese Kampo formulas .8
Bibliography .87
Foreword
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This document was prepared by Technical Committee ISO/TC 249, Traditional Chinese medicine.
iv © ISO 2018 – All rights reserved

Introduction
Herbal medicines have been developed around the world by utilizing available vegetation to develop
uses suitable for the physical constitution of the target population in each area.
Consequently, herbal prescriptions with the same name sometimes have different qualitative
composition and quantitative composition strength in different parts of the world. In other words,
there are plenty of polysemes (see ISO 1087-1) in the origin of crude drugs among some traditional
[20] [12]
medicines . The resulting confusion is further complicated by the use of similar letters in some
countries.
These issues cannot be ignored in the process of standardizing contemporary terminology for medicinal
products to keep with up-to-date drug information management policies, from clinical trials to post-
market surveillance in the periodic safety update report (PSUR).
Furthermore, therapeutic indications are defined only for medicinal products, but not for formulas
[21][22]
specified in some pharmacopoeias including Japan’s . It is important to take this into account in
international standardization though this has not yet been achieved in ISO/TC 249.
Therefore, this document describes the controlled vocabulary for formula names used in Japanese
Kampo formulas with the respective indications and efficacies of each product to avoid market
distortions and health hazards. The information provided in this document is expected to encourage
international trade.
Formulas or traditional medicines that are not controlled by the Japanese Pharmacopoeia and the
related official documents published by the Medicinal Regulatory Agency in Japan are beyond the scope
of this document.
TECHNICAL REPORT ISO/TR 23022:2018(E)
Traditional Chinese medicine — Controlled vocabulary on
Japanese Kampo formulas and the indication codes for the
products
1 Scope
This document specifies the controlled vocabulary for formulas used in Japanese Kampo medicine with
the therapeutic indications of each product according to the subset of IDMPs (ISO 11238, ISO 11615, ISO
[10] [15] [16 [17]
11616 , ISO 19844 , ISO/TS 20443 ], ISO/TS 20451 ).
This document is intended to be used by:
— traders and distributors of medicinal products in Kampo formulas and crude drugs used in Kampo
medicine;
— terminologists and developers of new terminological resources concerning herbal medicines in
Kampo medicine, and maintenance officers of existing terminological resources concerning Kampo
medicine to enable their conformance;
— informaticians, developers, or managers of HIS, EMR, or EHR systems concerning Kampo medicine;
— officers, analysts or maintenance personnel of national health statistics, and policy proposal staff of
national health policies;
— officers of WHO, and WHO statistics.
This edition of this document describes only medicinal products in accordance with the Kampo formula
in Japan. Both OTC Kampo formula medicinal products and in-pharmacy formula medicinal products
are omitted, although they are permitted under Japanese jurisdiction.
Topics considered out of scope of this document are:
— any medicinal products manufactured in accordance with the formula of traditional medicines that
are not permitted under the Japanese jurisdiction;
— whole information models of medicinal products, pharmaceutical products and substances (see ISO
11238) because those are already specified in IMDPs;
[13]
— any categorical structure(s) of herbal medicaments (see ISO/TS 18062, ISO 17115 and EN
[18]
12264 ).
The controlled vocabulary for formulas used in Japanese Kampo medicine is given in Annex A.
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 1087-1, Terminology work — Vocabulary — Part 1: Theory and application
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/TS 18062, Health informatics — Categorial structure for representation of herbal medicaments in
terminological systems
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1087-1, ISO 11238, ISO 11615
and ISO/TS 18062 and the following apply.
ISO and IEC maintain terminological 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
ingredient
material (3.8) that is used in the preparation of a medicinal product (3.9)/pharmaceutical product (3.13)
Note 1 to entry: An ingredient is a part of a medicinal product (3.9), either by itself or in combination with one or
more ingredients. An ingredient is also a component of a pharmaceutical product (3.13). An ingredient is equal to
a detailed description of a substance playing a role in a product.
3.2
jurisdiction
geographical area or subject matter in which the authority of the Medicines Regulatory Agency applies
3.3
legal status of supply
jurisdictional rule on whether a medicinal product requires a medical prescription before it can be
supplied to a patient or consumer
3.4
manufactured item
qualitative and quantitative composition of a product as described in the packaging of the medicinal
product (3.9)
Note 1 to entry: A medicinal product may contain one or more manufactured items.
Note 2 to entry: Pharmaceutical product (3.13) and manufactured item are sometimes different when
manufactured item(s) are processed before administration to the patient (as the pharmaceutical product).
Note 3 to entry: The manufactured item is not in direct contact with the outer packaging except where the outer
packaging also serves as the immediate container.
3.5
marketing authorization
authorization issued by a Medicines Regulatory Agency allowing a medicinal product (3.9) to be sold on
the market
3.6
marketing authorization holder
organization that holds the authorization for marketing a medicinal product in a jurisdiction
3.7
marketing authorization number
identifier assigned by a Medicines Regulatory Agency to a medicinal product (3.9)
2 © ISO 2018 – All rights reserved

3.8
material
substance or a specified substance of which a certain component is made
Note 1 to entry: This applies to medicinal products (3.9), packaging items (container), packages (component), and
devices.
3.9
medicinal product
any substance or combination of substances that may be administered to human beings (or animals)
to treat or prevent disease, to make a medical diagnosis, or to restore, correct, or modify physiological
functions
Note 1 to entry: A medicinal product may contain one or more manufactured items, and one or more
pharmaceutical products (3.13).
Note 2 to entry: In certain jurisdictions, a medicinal product may also be defined as any substance or a
combination of substances that may be used to make a medical diagnosis.
Note 3 to entry: [SOURCE: ENV 13607:2000, modified]
3.10
medicinal product identifier
MPID
unique identifier allocated to a medicinal product that supplements any existing marketing authorization
number as ascribed by a Medicines Regulatory Agency within a jurisdiction
Note 1 to entry: This identifier is for indexing purposes to contribute to improved patient safety by allowing for
the unique identification of medicinal products worldwide.
3.11
medicinal product name
name as authorized by a Medicines Regulatory Agency
Note 1 to entry: This may either be an invented name not liable to be confused with the common name, or a
common or a scientific name accompanied by a trademark or any other applicable descriptor.
3.12
medicines regulatory agency
institutional body that, according to the legal system under which it has been established, is responsible
for the granting of marketing authorization for medicinal products
Note 1 to entry: In certain jurisdictions, the role of the institutional body, which grants the marketing
authorization of medicinal products according to the legal system, may be complemented by an additional
institutional body responsible for the evaluation and supervision of medicinal product. For example, in the
EU, the European Commission is the institutional body that grants the marketing authorization of medicinal
products, and the European Medicines Agency is the body responsible for the evaluation and supervision of
medicinal products.
3.13
pharmaceutical product
qualitative and quantitative composition of a medicinal product in the dose form approved for
administration in line with regulated product information
Note 1 to entry: A medicinal
...