ISO 21300

• Abstract:

  This document specifies the general requirements for Chinese materia medica specification. This specification is relevant for dividing Chinese materia medica into categories. It provides guidelines for writing the specifications of individual Chinese materia medica.

• Status: Not Published
• ICS: 11.020.99 - Other standards related to health care in general
• Technical Committee: ISO/TC 249 - Traditional Chinese medicine
• Drafting Committee: ISO/TC 249/WG 1 - Quality and safety of raw materials and traditional processing
• Current Stage: 6000 - International Standard under publication
• Start Date: 10-Sep-2026
• Completion Date: 12-Sep-2026

• Revises: ISO 21300:2019 - Traditional Chinese medicine — Guidelines and specification for Chinese materia medica
• Effective Date: 08-Feb-2025

Overview

ISO 21300: Traditional Chinese Medicine - Guidelines and Specification for Chinese Materia Medica sets out the general requirements for the specification and categorization of Chinese materia medica (CMM). Developed by the International Organization for Standardization (ISO), this standard provides a clear structure for writing, dividing, and identifying CMM, supporting consistency, safety, and quality within the traditional Chinese medicine (TCM) sector globally. With the growing international trade of CMM, unified guidelines are essential for ensuring product quality, improving clinical outcomes, and facilitating regulatory acceptance.

Key Topics

ISO 21300 covers essential aspects for standardizing Chinese materia medica:

• General Requirements and Recommendations: The document details recommendations for determining total ash, sulfated ash, ash insoluble in hydrochloric acid, heavy metals, foreign matter, identification of marker compounds, pesticide residues, sulfur dioxide, and aflatoxin contents.
• Specification Indicators: Guidelines for documenting and differentiating CMM based on:
  • Origin: Biological source and geographic origin affecting quality and categorization.
  • Growing Method: Differentiation between wild and cultivated material.
  • Medicinal Parts: Specification of the part used (root, stem, leaf, etc.).
  • Harvest Time: Influence of collection season on quality.
  • Primary Processing: Standard procedures for post-harvest handling.
  • Extraneous Matter Rate: Quantification and report of non-medicinal impurities.
  • Morphology: Criteria such as individual count per weight, length, thickness, diameter, and color to distinguish categories.
• Marking, Labelling, Packaging, and Storage: Requirements for product identification (including compliance with ISO 21371 for labelling), suitable packaging methods, and proper transport and storage to maintain quality.

Applications

ISO 21300 is intended for a broad range of stakeholders in the traditional Chinese medicine field:

• Manufacturers & Suppliers: Enables consistent product specification, improves product traceability, and supports compliance with international best practices.
• Regulatory Agencies: Offers a unified reference framework for assessing imports, exports, and market surveillance of Chinese materia medica.
• Healthcare Providers: Assures practitioners and pharmacists about quality and safety through standardized information, benefitting clinical decision-making.
• Research and Development: Facilitates quality control, scientific research, and innovation by providing clear criteria for categorization, collection, and documentation of CMM.
• Quality Management: Assists in harmonizing procurement and supply chain management for raw TCM materials.

Related Standards

Implementing ISO 21300 can be complemented by referencing the following international standards:

• ISO 21371 - Traditional Chinese medicine - Labelling requirements of products intended for oral or topical use: Sets comprehensive labelling and product information requirements for TCM products.
• ISO 18662-1 - Traditional Chinese medicine - Vocabulary - Part 1: Chinese Materia Medica: Provides key terminology and definitions to ensure consistent communication across the supply chain.

In summary: ISO 21300 is a vital standard that drives harmonization in the traditional Chinese medicine sector. It ensures the safe, effective, and quality-assured use of Chinese materia medica worldwide by delivering clear guidance on specification, categorization, labelling, and handling of these critical herbal materials.

FINAL DRAFT
International
Standard
ISO/FDIS 21300
ISO/TC 249/SC 1
Traditional Chinese medicine —
Secretariat: SAC
Guidelines and specification for
Voting begins on:
Chinese materia medica
2026-07-15
Médecine traditionnelle chinoise — Lignes directrices et
Voting terminates on:
spécification relatives aux matières médicales chinoises
2026-09-09
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
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/FDIS 21300:2026(en) © ISO 2026

FINAL DRAFT
ISO/FDIS 21300:2026(en)
International
Standard
ISO/FDIS 21300
ISO/TC 249/SC 1
Traditional Chinese medicine —
Secretariat: SAC
Guidelines and specification for
Voting begins on:
Chinese materia medica
Médecine traditionnelle chinoise — Lignes directrices et
Voting terminates on:
spécification relatives aux matières médicales chinoises
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
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/FDIS 21300:2026(en) © ISO 2026

ii
ISO/FDIS 21300:2026(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Recommedations . 2
4.1 Total ash .2
4.2 Sulfated ash .2
4.3 Ash insoluble in hydrochloric acid .2
4.4 Heavy metals .2
4.5 Foreign matter .2
4.6 Identification .2
4.7 Pesticide residues .2
4.8 Sulfur dioxide . .2
4.9 Aflatoxin .2
5 Specificiation indicators . 3
5.1 Origin .3
5.2 Growing method .3
5.3 Medicinal parts .4
5.4 Harvest time .4
5.5 Primary processing .5
5.6 Extraneous matter rate .5
5.7 Morphology . .6
5.7.1 Individual number per 500 g .6
5.7.2 Length per piece .6
5.7.3 Thickness per piece .7
5.7.4 Diameter per piece.7
5.7.5 Colour .8
6 Marking, labelling, packaging, transport and storage . 8
6.1 Marking and labelling .8
6.2 Packaging .8
6.3 Transport and storage .8
Bibliography . 9

iii
ISO/FDIS 21300:2026(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 249, Traditional medicine, Subcommittee SC 1,
Traditional Chinese medicine.
This second edition cancels and replaces the first edition (ISO 21300:2019), which has been technically
revised.
The main changes are as follows:
— Title of Clause 4 has been changed from "Requirements" to “Recommendations”;
— 4.4, 4.5,4.6, 4.7, 4.8,4.9, the word “shall” has been changed to “should”.
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/FDIS 21300:2026(en)
Introduction
Chinese materia medica is a special commodity used for preventing and treating diseases. As an important
component of traditional medicine, the quality of Chinese materia medica directly affects clinical efficacy
and safety. However, due to the wide range of sources and diverse cultivation and processing methods of
Chinese materia medica, there is a lack of unified standards for the specifications of Chinese materia medica
in the global market, resulting in uneven quality and causing inconvenience to the production, circulation
and use of Chinese materia medica. In order to ensure the quality of Chinese materia medica, it is important
to establish a unified standard for the specifications of Chinese materia medica.
There are many factors that affect the specific
...

Formatted: French (France)
ISO/DISFDIS 21300
Formatted: French (France)
ISO/TC 249/SC 1
Secretariat: SAC
Date: 2026-03-2707-01
Traditional Chinese medicine — Guidelines and specification for
Chinese materia medica
Médecine traditionnelle chinoise — Lignes directrices et spécification relatives aux matières médicales
chinoises
DISFDIS stage
VVoottiing bng beegiginsns o on:n: 202 20255--0505--2828
VoVotintingg t tererminminatateses o onn:: 22002255--0088--2020

ISO/DISFDIS 21300:2026(en)
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication
may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying,
or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO
at the address below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: + 41 22 749 01 11
Formatted: French (France)
E-mail: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO/DISFDIS 21300:2026(en)
Contents
Foreword . iii
Introduction . iii
Scope . iii
Normative references . iii
Terms and definitions . iii
Recommedations . iii
Total ash . iii
Sulfated ash . iii
Ash insoluble in hydrochloric acid . iii
Heavy metals . iii
Foreign matter . iii
Identification . iii
Pesticide residues . iii
Sulfur dioxide . iii
Aflatoxin . iii
Indicators of the specification . iii
Origin . iii
Growing method . iii
Medicinal parts . iii
Harvest time . iii
Primary processing . iii
Extraneous matter rate . iii
Morphology . iii
Marking, labelling, packaging, transport and storage . iii
Marking and labelling . iii
Packaging . iii
Transport and storage . iii
Bibliography . iii
Foreword . v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Recommedations . 2
4.1 Total ash . 2
4.2 Sulfated ash . 2
4.3 Ash insoluble in hydrochloric acid . 2
4.4 Heavy metals . 2
4.5 Foreign matter . 2
4.6 Identification . 2
4.7 Pesticide residues . 3
4.8 Sulfur dioxide . 3
4.9 Aflatoxin . 3
5 Specificiation indicators . 3
5.1 Origin . 3
iii
ISO/DISFDIS 21300:2026(en)
5.2 Growing method . 4
5.3 Medicinal parts . 4
5.4 Harvest time . 5
5.5 Primary processing . 6
5.6 Extraneous matter rate . 7
5.7 Morphology . 8
6 Marking, labelling, packaging, transport and storage . 13
6.1 Marking and labelling . 13
6.2 Packaging . 13
6.3 Transport and storage . 13
Bibliography . 14

iv
ISO/DISFDIS 21300:2026(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 documentsdocument 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).
Field Code Changed
Attention is drawnISO draws attention to the possibility that some of the elementsimplementation of this
document may beinvolve the subjectuse 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. 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 (see
www.iso.org/patents).
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),
see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 249, Traditional medicine, Subcommittee SC 1,
Traditional Chinese medicine.
This second edition cancels and replaces the first edition (ISO 21300:2019), which has been technically
revised.
The main changes are as follows:
— — the titleTitle of Clause 4 has been changed from "Requirements" to “Recommendations”;
Formatted: List Continue 1
— — in 4.4, 4.5,4.6, 4.7, 4.8,4.9, the word “shall” has been changed to “should”;”.
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
ISO/DISFDIS 21300:2026(en)
Introduction
Chinese materia medica is a special commodity used for preventing and treating diseases. As an important
component of traditional medicine, the quality of Chinese materia medica directly affects the clinical efficacy
and safety. However, due to the wide range of sources and diverse cultivation and processing methods of
Chinese materia medica, there is a lack of unified standards for the specifications of Chinese materia medica
in the global market, resulting in uneven quality and causing inconvenience to the production, circulation and
use of Chinese materia medica. In order to ensure the quality of Chinese materia medica, it is particularly
important to establish a unified standard for the specifications of Chinese materia medica.
There are many factors tha
...