Traditional Chinese medicine -- Controlled vocabulary on Japanese Kampo formulas and the indication codes for the products

ISO/TR 23022:2018 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 11616[10], ISO 19844[15], ISO/TS 20443[16], ISO/TS 20451[17]). ISO/TR 23022:2018 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 ISO/TR 23022:2018 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; - any categorical structure(s) of herbal medicaments (see ISO/TS 18062, ISO 17115[13] and EN 12264[18]). The controlled vocabulary for formulas used in Japanese Kampo medicine is given in Annex A.

Médecine traditionnelle chinoise - Vocabulaire contrôlé relatif aux formules Kampo japonaises et codes d'indication des produits

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Publication Date
23-Apr-2018
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6060 - International Standard published
Start Date
24-Mar-2018
Completion Date
24-Apr-2018
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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/TR 23022:2018(E)
ISO 2018
---------------------- Page: 1 ----------------------
ISO/TR 23022:2018(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2018

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

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Published in Switzerland
ii © ISO 2018 – All rights reserved
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ISO/TR 23022:2018(E)
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

© ISO 2018 – All rights reserved iii
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ISO/TR 23022:2018(E)
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

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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. www .iso .org/directives

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received. www .iso .org/patents

Any trade name used in this document is information given for the convenience of users and does not

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URL: www .iso .org/iso/foreword .html.

This document was prepared by Technical Committee ISO/TC 249, Traditional Chinese medicine.

iv © ISO 2018 – All rights reserved
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ISO/TR 23022:2018(E)
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.
© ISO 2018 – All rights reserved v
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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

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ISO/TR 23022:2018(E)

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
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ISO/TR 23022:2018(E)
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 product can contain one or more pharmaceutical products.

Note 2 to entry: Pharmaceutical product and manufactured item (3.4) are sometimes different when manufactured

item(s) are processed before administration to the patient [as the pharmaceutical product (3.13)].

3.14
pharmaceutical product identifier
PhPID
unique identifier for a pharmaceutical product
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ISO/TR 23022:2018(E)
3.15
product classification
categorization or grouping of medicinal products based on specific properties
EXAMPLE Pharmacological classification, classification by therapeutic effect.
3.16
qualitative composition

composition of all the constituents of the investigational or authorized medicinal product, if applicable,

after reconstitution, and the functioning of the constituents of:
— the substance and the specified substance;

— the constituent(s) of the excipients, whatever their nature or quantity used, including colouring

materials, preservatives, adjuvants, stabilizers, thickeners, emulsifiers, flavouring, and aromatic

substances, etc.
3.17
quantitative composition strength

amounts of substance and specified substance constituents in the investigational or authorized

medicinal product expressed in a ratio scale

Note 1 to entry: It is necessary for the quantitative composition of the substance(s) or the specified substance

descriptions of the finished investigational or authorized medicinal products (depending on the pharmaceutical

form concerned) to specify the mass, or the number of units of biological activity, either as a per dosage unit or as

per unit of mass or volume, of each substance or specified substance.

Note 2 to entry: Substance or specified substance descriptions present in the form of compounds or derivatives

are always designated quantitatively by their total mass and, if necessary or relevant, by the mass of the active

entity, or entities, of the molecule.
3.18
target population

type of patients or consumers for which the indication of a medicinal product (3.9) is authorized

3.19
therapeutic indication

intended use of the medicinal product (3.9) as authorized by the Medicines Regulatory Agency in a

jurisdiction

Note 1 to entry: For clinical trials, this refers to the intended use under investigation and as described in the

clinical trial protocol.
3.20
Kampo
kampo medicine
traditional medicine that has been developed in Japan

Note 1 to entry: Ancient Chinese medicine was introduced to Japan. After around 1 600 years, Kampo medicine

has diverged from the ancient Chinese medicine.
3.21
kampo formula

combination of crude drugs (3.24) used in Kampo medicine (3.20), that is defined or authorized by the

[21][22][23]
Medicines Regulatory Agency and in Japan

Note 1 to entry: Medicinal products (3.9) made with this type of formula are supplied only when modern medical

doctors order prescriptions. Cf. legal status of supply (3.3).
4 © ISO 2018 – All rights reserved
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ISO/TR 23022:2018(E)
3.22
OTC kampo formula

combination of crude drugs (3.24) based on Kampo medicine (3.20), that is defined or authorized by the

[21][22][23]
Medicines Regulatory Agency in Japan

Note 1 to entry: Medicinal products (3.9) in accordance with this type of formula are supplied for the use of self-

medication. Cf. legal status of supply (3.3).
3.23
in-pharmacy Kampo formula

combination of crude drugs based on Kampo medicine, defined or authorized by the Medicines

Regulatory Agency in Japan

Note 1 to entry: Medicinal products (3.9) in accordance with this type of formula are produced in pharmacies. Cf.

legal status of supply (3.3).
3.24
crude drug

natural medicine that is used as a component of a Kampo formula (3.21) defined or authorized in the

[21][22]
Japanese Pharmacopeia and its addenda
3.25
part of interest
medicinal part

part of a natural material (3.8) that is usable as source material for a crude drug (3.24)

EXAMPLE Seed, root, rhizome, stem, bark, leaf, bud, flower, fruit.
3.26
origin

definition of crude drug (3.24) including the name of the natural material (3.8) and the part of interest

for medicinal use
3.27
medical domain
specific concepts and generic concepts of various medical systems
Note 1 to entry: Modern medicine is also a type of medical domain.

EXAMPLE Modern medicine, Ayurveda, traditional African medicine, traditional Australian (Aboriginal),

traditional Canadian, Chinese or traditional Chinese (TCM), traditional Japanese (Kampo), traditional Korean,

Mongolian, New Zealand (Maori), Thailand, Tibetan, or Vietnamese, and so on.

Note 2 to entry: Other country's pharmacopeia(s) or portion(s) of it may substantially indicate a certain

medical domain.
3.28
batch

specific manufacturing release of a medicinal product (3.9) or item by the manufacturer

4 Abbreviated terms
BAID_1 Medicinal Product Batch Identifier (outer packaging)
BAID_2 Medicinal Product Batch Identifier (immediate packaging)
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ISO/TR 23022:2018(E)
5 Conformance
The Japanese jurisdiction claims the following:

— crude drugs and pharmaceutical products using the Kampo formula shall conform to the Japanese

[21][22];
Pharmacopeia and its addenda

— medicinal products using the Kampo formula shall conform to the Japanese Pharmacopeia and its

[21][22]
addenda ;

— the medicinal product names of Kampo formula and their expression with letters shall conform to

[21]21]
the Japanese Pharmacopeia and its addenda .

NOTE 1 Chemical and physical identification methods for substances in Kampo medicine are described in

[21][22]

the Japanese Pharmacopeia and its addenda . Some examples of these methods as well as genetic data are

accessible from the website of the Research Center for Medicinal Plant Resources of the National Institute of

[24]
Biomedical Innovation .
[20][21][22]

NOTE 2 Many crude drug names in traditional medicines are polysemes. Such confusion is further

[3]
aggravated by the use of similar letters or scripts in various countries.

NOTE 3 To avoid confusion caused by similarities in naming, the names of the Kampo formula defined by

[21][22][23]

the Japanese Medicines Regulatory Authority are expressed with a superscript symbol . Such a


symbol has three purposes: 1) to give attention to the recognition of the different meaning, 2) to prohibit

inaccurate conversion of letters, and 3) to help distinguish between homonyms and polysemes (see ISO 1087-1

and References [1][2][3] and [12].

NOTE 4 Each medicinal product name using the Kampo formula contains names defined by the Japanese

[21][22][23]

Medicines Regulatory Authority . In other words, medicinal product names using the Kampo formula

in the same product classification contains the name of the Kampo formula defined by the Japanese Medicines

[21][22][23]
Regulatory Authority .

EXAMPLE 1 The symbol is added as superscript to the Latin name of crude drugs used in Kampo medicine

in this document in order to distinguish crude drugs in Kampo medicine from those in the Chinese Materia

[14] [21]

Medica , 3.86. For example, the Latin name BUPLEURI RADIX , 7.2.29, is defined as the root of Bupleurum

[14]

falcatum Linné (Umbelliferae), but the Latin name of Bupleuri radix in the Chinese Materia medica , 3.86, is

defined as the root of Bupleurum chinense DC. or Bupleurum scorzonerifolium Willd.


EXAMPLE 2 ANGELICAE RADIX , Japanese Angelica Root , and 当当 is defined as the root of Angelica

acutiloba Kitagawa or Angelica acutiloba Kitagawa var. sugiyamae Hikino (Umbelliferae), usually after being

[14]

passed through hot water (7.2.9 in Reference [21]). This is different from 当当in the Chinese Materia medica ,

3.38, which is defined as the root of Angelica sinensis (Oliv.) Diels.
6 Coding system

ISO 11615 requires the description of the concepts of MPID with PhPID(s), BAID_1, and BAID_2. Those

mainly focus on the following entries:
— name of the medicinal product;
— legal status of supply;
— terms of the marketing authorization;
— marketing authorization (licence) holder;
— manufacturer(s);
— authorizing Medicines Regulatory Agency;
— qualitative and quantitative compositions;
— ingredients, strength, pharmaceutical form, route of administration;
6 © ISO 2018 – All rights reserved
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ISO/TR 23022:2018(E)
— device(s) as part of a medicinal product;
— clinical particulars, especially authorized therapeutic indication(s);
— product classification(s);
— package description;
— regulated product information and documentation.

It is explicitly or implicitly expected that the above are described with the following:

[6][7][8]
— country code ;
— the marketing authorization number;
— unique identification of a medicinal product and the associated PhPID(s).
© ISO 2018 – All rights reserved 7
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ISO/TR 23022:2018(E)
Annex A
(informative)
Controlled vocabulary of Japanese Kampo formulas
A.1 Names and the specifics of Japanese Kampo formulas

This document covers only Kampo medicine. In Japan, the Medicines Regulatory Agency is the Ministry

of Health, Labour, and Welfare (of Japan).

Authorized formulas and their names are defined in Japanese Pharmacopeia, its official addenda and

[21][22]

related document . Some formula has variation in qualitative and quantitative composition.

Qualitative and quantitative composition is simply expressed as the composition of crude drugs and

their amount in weight.

The Kampo formulas consist of some crude drugs, and both of them are defined in Japanese

[21][22]

Pharmacopeia and its official addenda . The definitions of crude drug are not only specifying

scientific names of the origins and the part of interest(s) but also laboratory tests and test methods.

The “approved number” are able to use as the marketing authorization number. The minister or

the prefectural governors hold the authority to provide those numbers, and this information is also

embedded in the marketing authorization number.

Authorized names of medicinal products in Kampo medicinal product are expressed in Japanese

Katakana, Hiragana, Kanji letters, and English text.
[21][22]

No therapeutic indications are specified in Japanese Pharmacopeia and in its official addenda .

One reason is that medicinal products are manufactured with various ingredients other than active

substances (ISO 1087-1, References [7] and [8]). Consequently, the characteristics of medicinal products

are different from each other although they are manufactured conforming to the same formula and then

they are belonging to the same product classification. Another reason is because therapeutic indications

and contra-indications are immediately updated on the results of “post marketing surveillance” in Japan.

In this document, therapeutic indications are described in English text as well as ICD codes that are

linked from the “medical insurance reimbursement code in Japan” used in EMR systems or HIS.

Table A.1 — Summary of fixed values for indication coding of medicinal products in Kampo

in Japan
fixed: the Ministry of Health, La-
authorizing Medicines Regulatory Agency
bour, Welfare
with country code fixed: Japan
name of authorized formula
with country code fixed: Japan
authorized qualitative and quantitative
composition
and its authorized variation, if existing
embedded in marketing authoriza-
tion number.
marketing authorization (licence) holder
actually fixed for the medicinal
product for Kampo formula, the
Minister of MHLW.
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ISO/TR 23022:2018(E)
Table A.1 (continued)
embedded in marketing authoriza-
tion number.
maybe with subdivision code
actually used for the medicinal prod-
uct fonly for OTC Kampo formula.
marketing authorization number for me-
dicinal product
substituted by marketing authoriza-
unique identifier of a medicinal product
tion number.
authorized name of the medicinal product
in conformance with qualitative and
actual composition
quantitative composition
manufacturer includes VAR
with country code
authorized therapeutic indications for
medicinal product
scope for therapeutic indications —
country code fixed: Japan
medical domain fixed: modern medicine
Indication text
Indication as “disease/symptom/proce-
dure”
A.2 Binding indications to each medicinal product of Japanese Kampo formula
A.2.1 Presented items, notes, and sources

The fixed value items in Table A.1 are omitted, then, presented items (bold-faced), notes, and

information sources are illustrated in Table A.2.
Table A.2 — Presented items (bold-faced), notes, and information sources
Japanese Pharmacopeia, its addenda
name of authorized formula
[21][22][23]
and related document .
authorized qualitative and quantitative Japanese Pharmacopeia, its addenda
[21][22][23]
composition and related document , this
and its authorized variation, if existing item is not presented in A.2.2.
package insert in each medicinal
[15][16][17]
product .
marketing authorization number for me-
surrogate for unique identifier of a
dicinal product
medicinal product, this item is shown
as the anonymous number in A.2.2.
package insert in each medicinal
[15][16][17]
authorized name of the medicinal product product , this item is not
presented in A.2.2.
in conformance with authorized
actual composition composition, expressed as composi-
[21][22]
tion of crude drugs .
package insert in each medicinal
[15][16][17]
manufacturer product , this item is not
presented in A.2.2.
with country code fixed: Japan
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ISO/TR 23022:2018(E)
Table A.2 (continued)
authorized therapeutic indications for package insert in each medicinal
[15][16][17]
medicinal product product .
package insert in each medicinal
Indication text
[15][16][17]
product .
Indications as “disease/symptom/pro-
Compendiums of Kampo medi-
cedure”
[25][26][27]
cines .
with controlled terms/identifiers

In the tables under A.2.2, each Kampo medicinal product is classified in the Clause of corresponding

Kampo formula. Each Clause has two tables: One is for indications, and the other illustrates the

composition of each Kampo medicinal product.

In the first table, the values of “Controlled identifiers” are paired: the former one is “the codes used

in Hospital Information Systems in Japan” and these codes are used for reimbursement of medical

[27]
insurance. The latter one is ICD-10 code that is mapped from the former code .

In the second table, “Product No.” is the anonymous number for the actual marketing authorization

[27]
number of Kampo medic
...

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