ISO/DTR 23975

Reference number of working document: ISO/TC 249/N
ISO/TR 23975:2024(en)
Date: 2024-07-1909-16
Reference number of document: 23795
Committee identification: ISO/TC 249/WG 1
Secretariat: SAC
Traditional Chinese medicine — Priority list of single herbal medicines for
developing standards
i © ISO 2024 – All rights reserved

ISO/TR 23975: 2024(E)
Document type: Technical report
Document subtype: if applicable
Document stage: TBATBA
Document language: E
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ISO/TR 23975:2024(en)
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iii
ISO/TR 23975: 2024(E)
Contents Page
Foreword . v
Introduction . vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Document structure . 1
5 Principles . 2
6 Evaluation indexes . 2
6.1 International trade . 2
6.2 Single herbal medicines recorded in pharmacopoeias . 12
6.3 Safety concerns . 81
6.4 The use frequency of single herbal medicines in formula recorded in
Pharmacopoeias and national formula . 98
6.5 Single herbal medicine standards published or under development . 123
6.6 Endangered species . 126
7 Data processing . 128
7.1 The weight coefficient of evaluation indexes distribution . 128
7.2 The range of priority rank distribution . 128
7.3 Data statistics . 129
8 Single herbal medicines in order of priority . 129
Annex A (informative) Priority list of single herbal medicines ranked from 151 to 375
......................................................................................................................................................... 144
Bibliography . 163
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ISO/TR 23975:2024(en)
Foreword
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This document was prepared by Technical Committee ISO/TC 249, Traditional Chinese medicine.
5 © ISO 2024 – All rights reserved
v
ISO/TR 23975: 2024(E)
This second edition cancels and replaces the first edition (ISO/TR 23975:2019) which has been
technically revised.
The main changes are as follows:
— in 5.1, the international trading value of herbal medicines was replaced by the international trade
volume as a high priority principle;
— in 5.4, a new principle of high priority was added;
— in 6.1, the data of international trade volume for single herbal medicines was updated,; and
Table 1 was sorted by international trade volume;
— in 6.2, the data of single herbal medicines recorded in pharmacopoeias was updated,; and Table 2
was sorted by occurrence count;
— in 6.4, the data of the use frequency for single herbal medicines in formula recorded in
Pharmacopoeias and national formula was added,; and Table 4 was sorted by occurrence count;
— in6in 6.5, the data of international standard for single herbal medicines that have been published
or are under development was updated, and listed in Table 5;
— in 6.6, single herbal medicines that are listed as endangered species in CITES were updated;
— in 7.1, the weight coefficient of criteria for developing single herb standards based on recent
expert consultation werewas updated, and listed in Table 7;
— in 7.2, the range of priority rank for developing single herb standards based on recent expert
consultation werewas updated, and listed in Table 8;
— in Clause 8, Table 9 was updated;
— in Annex A, Table A.1 was updated.
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.
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ISO/TR 23975:2024(en)
Introduction
Being a significant part of traditional medicine systems and general health services, traditional
Chinese medicine is estimated to be used in over 180 countries and regions around the world. This
is reflected by the statistics cited from the WHO report that there are 4 billion people in the world
using herbal medicines, accounting for 80 % of the total world population. Asia, North America, and
Europe are regarded as the major markets for herbal medicines. Moreover, incomplete Chinese
customs statistics show that the import and export of herbal medicine products in China was worth
over 1,61 billion USD in 2023. Therefore, it is very important to develop globally harmonized
standards in order to ensure the safety of consumers. In particular, those herbal medicines which
have been reported to cause adverse drug reactions (ADR) are drawing much attention from national
health administrations.
There are a great number of single herbs on the market; for instance, 618 kinds of herbs have been
included in the Pharmacopoeia of the People's Republic of China. Currently, organizations, regions and
countries including ISO, WHO, the European Union, China, Japan, Korea, the USA, the UK and Thailand
are making valuable contributions by developing standards for single herbs. This document presents
a list of single herbal medicines in order of priority for the purposes of developing standards on single
herbs in a scientific and orderly manner. This document can be used as a reference by any
organization wishing to develop standards on single herbal medicines.
The following factors have been considered in setting the priorities:
— the trade volume of each single herbal medicine in the global market;
— whether the herbal medicine is recorded by the Pharmacopoeia of the People's Republic of China,
the European Pharmacopoeia, the Japanese Pharmacopoeia, the Japanese standards for non-
Pharmacopoeial crude drugs, the Korean Pharmacopoeia, the Korean Herbal Pharmacopoeia, the
Thai Herbal Pharmacopoeia, Hong Kong Chinese Materia Medica Standards or the United States
Pharmacopoeia;
— whether there are potential risks from its use;
— whether the herbal medicine is used in formula by the Pharmacopoeia of the People's Republic of
China, the Japanese Pharmacopoeia, the Korean Pharmacopoeia, or other national formula;
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vii
ISO/TR 23975: 2024(E)
— whether the herbal medicine is listed in the Convention on International Trade in Endangered
Species of Wild Fauna and Flora (CITES);
— opinions from experts.
8 © ISO 2024 – All rights reserved

Technical Report ISO/TR 23975:2024(en)

Traditional Chinese medicine — Priority list of single herbal
medicines for developing standards
1 Scope
This document provides a reference of single herbal medicines in order of their priority in the
development of international standards.
This document also provides a reference of the principles and the methodology for the priority
evaluation of single herbal medicines.
2 Normative references
There are no normative references in this document.
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 http://www.electropedia.org/
4 Document Structuresstructure
4.1 Firstly, the The principles for determing the priority of single herbal medicines in the order of
their priority are established in Clause 5.
4.2 Secondly, single Single herbal medicines and the data of evaluation indexes are listed in Clause 6.
4.3 Thirdly, the The methods of data statistics, including the weight coefficient of evaluation indexes
and the range of priority rank, are determined in Clause 7.
ISO/TR 23975: 2024(E)
4.4 Finaly, the The priority list of single herbal medicines is established in Clause 8 based on the
evaluation indexes data in Clause 6 and the statistical methods in Clause 7. At the same time, theThe
non-priority list of single herbal medicines is also obtainedprovided in Annex A.
5 Principles
5.1 Herbal medicines which have a large international trade volume are listed as high priority in
Table 1.
5.2 Common herbal medicines recorded in the Pharmacopoeia of the People's Republic of China, the
European Pharmacopoeia, the Japanese Pharmacopoeia, the Japanese standards for non-
Pharmacopoeial crude drugs, the Korean Pharmacopoeia, the Korean Herbal Pharmacopoeia, the Thai
Herbal Pharmacopoeia, Hong Kong Chinese Materia Medica Standards, and the United States
Pharmacopoeia are listed as high priority in Table 2.
5.3 Herbal medicines that have safety concerns, such as those widely reported to cause adverse drug
reactions (ADR), are listed as high priority in Table 3.
5.4 Herbal medicines which have a high frequency of use in formula recorded in the Pharmacopoeia
of the People's Republic of China, the Japanese Pharmacopoeia, the Korean Pharmacopoeia, and other
national formula are listed as high priority in Table 4.
5.5 Single herbal medicines for which there are existing ISO standards are listed as high priority in
Table 5.
5.6 Herbal medicines which are included in
...