ISO/TR 23975:2025
(Main)Traditional Chinese medicine — Priority list of single herbal medicines for developing standards
Traditional Chinese medicine — Priority list of single herbal medicines for developing standards
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. In addition to text written in the official ISO languages (English, French, Russian), this document gives text in Chinese. This text is published under the responsibility of the Member Body for China (SAC) and is given for information only. Only the text given in the official languages can be considered as ISO text.
Médecine traditionnelle chinoise — Liste prioritaire de médicaments à base de plantes isolées pour l'élaboration de normes
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Standards Content (Sample)
Technical
Report
ISO/TR 23975
Second edition
Traditional Chinese medicine —
2025-01
Priority list of single herbal
medicines for developing standards
Médecine traditionnelle chinoise — Liste prioritaire de
médicaments à base de plantes isolées pour l'élaboration de normes
Reference number
© ISO 2025
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ii
Contents Page
Foreword .iv
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Document structure . 1
5 Principles . 1
6 Evaluation indexes . 2
6.1 International trade .2
6.2 Single herbal medicines recorded in pharmacopoeias .6
6.3 Safety concerns . 46
6.4 The use frequency of single herbal medicines in formula recorded in Pharmacopoeias
and national formula . 54
6.5 Single herbal medicine standards published or under development .71
6.6 Endangered species . 73
7 Data processing . 74
7.1 The weight coefficient of evaluation indexes distribution .74
7.2 The range of priority rank distribution .74
7.3 Data statistics . 75
8 Single herbal medicines in order of priority .75
Annex A (informative) Priority list of single herbal medicines ranked from 151 to 375 .83
Bibliography .94
iii
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
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with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
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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 249, Traditional Chinese medicine.
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;
— in 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 was updated, and listed in Table 7;
— in 7.2, the range of priority rank for developing single herb standards based on recent expert consultation
was updated, and listed in Table 8;
— in Clause 8, Table 9 was updated;
iv
— in Annex A, Table A.1 was updated.
In addition to text written in the official ISO languages (English, French, Russian), this document gives text
in Chinese. This text is published under the responsibility of the Member Body for China (SAC) and is given
for information only. Only the text given in the official languages can be considered as ISO text.
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.
v
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;
— whether the herbal medicine is listed in the Convention on International Trade in Endangered Species of
Wild Fauna and Flora (CITES);
— opinions from experts.
vi
Technical Report ISO/TR 23975:2025(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 structure
4.1 The principles for determing the priority of single herbal medicines are established in Clause 5.
4.2 Single herbal medicines and the data of evaluation indexes are listed in Clause 6.
4.3 The methods of data statistics, including the weight coefficient of evaluation indexes and the range of
priority rank, are determined in Clause 7.
4.4 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. The non-priority list of single herbal medicines is
provided 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 fre
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