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Chinese Traditional Medical Journal 

 

The Present State of Chinese Traditional Chinese Medicine 

Standardization 
 

Narasimha, Jayalaxmi 
Received on:  21 Dec 2024   Revised on: 20 Jan 2024    Accepted Date: 25 Feb 2024  

Published on: 13 March 2025 
 

 

1. Introduction 

 

Traditional Chinese Medicine (TCM) has a long 

history of use in the treatment and prevention of 

illness [1]. The natural treatment of traditional 

Chinese medicine (TCM) is gaining popularity 

across the globe due to its safety, efficacy, and 

widespread usage [2]. Traditional Chinese 

Medicine (TCM) has expanded into a worldwide 

industry and has reached over a hundred nations, 

according to the World Health Organization's 

Traditional Medicine Strategy: 2014–2023. [3]. 

Unfortunately, the growth of TCM is hindered and 

the progress of globalization and modernization of 

TCM is greatly affected by the absence of 

necessary standards [4, 5].  

China has a distinct TCM theoretical framework 

and efficient treatment procedures since it is the 

birthplace and primary user of TCM. While there 

have been tremendous strides in standardizing 

TCM in recent years—thanks to the ongoing 

evolution of both ideas and methods—certain 

challenges persist [6]. With the exception of 

acupuncture, moxibustion, and traditional Chinese 

medicines, this article mostly summarizes and 

analyzes studies on the present state of TCM 

standardization [7]. 

 

 

 

 

 

 

 

 

 

 

 

 

 

2. Current Status of Standardization of 

Traditional Chinese Medicine in China 

 

The Chinese Government Places a High Priority 

on TCM Standardization (2.1). Following the 

principle of "uni-fication, simplification, 

coordination, and optimization" and making full 

use of it, traditional Chinese medicine (TCM) 

standardization involves creating and 

implementing rules for all aspects of TCM, 

including medical care, research, education, 

industry, culture, and management. The goals are 

to advance TCM in academia and spread its 

achievements, standardize its management, 

ensure its quality and safety, encourage its 

modernization and international communication 

for the benefit of society and the economy, and 

guide and support a range of initiatives aimed at 

the comprehensive development of TCM [8]. As 

part of its modernization, TCM must be 

standardized. An item mentioning "promoting 

the standardization of TCM" was added in the 

2009 Opinions of the State Council on 

Supporting and supporting the Development of 

Traditional Chinese Medicine from the State 

Council of China. 



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"The construction for the standardization of TCM should 

be strengthened," emphasised Comrade Li Keqiang, a member 

of the Central Politburo Standing Committee of the 

Communist Party of China and Vice Premier of the State 

Council, during the 2011 National Work Conference on 

Traditional Chinese Medicine.  

"Promotion of standardization and normalization of TCM" is 
listed as an essential priority in the Twelfth Five-Year 

Planning Outline for National Economic and Social 

Development of the People's Republic of China by the 

National Development and Reform Commission. In the 2006–

2020 Traditional Chinese Medicine Innovation Development 

Planning Outline, spearheaded by the Ministry of Science and 

Technology, TCM standardization was identified as a priority 

issue with the aim of becoming the worldwide standard for 

traditional medicine. Supporting traditional Chinese medicine 

(TCM) as a promising area for global innovation, the People's 
Republic of China's Standardization Administration has 

included almost hundreds of TCM standard items in its 

strategy for service standard development.  

Chinese Traditional Chinese Medicine's Standard System Is 

Mostly Defined in the Country. The TCM standard system 

was mostly formed during the "Eleventh Five-Year Plan" era. 

Standards for management, fundamental operations, technical 

operations, and working conditions make up the system [9], 

with an emphasis on the development and updating of the 

former two types of standards.  
Chinese Traditional Chinese Medicine (TCM) Basic 

Standards: Where We Are Now 2.2. Basic theoretical 

terminology, terminology of specific TCM subjects and their 

classification and codes, and other standards to achieve TCM 

terminology standardization were the initial foci of the 

formulation and revision of basic and general standards of 

Traditional Chinese Medicine. Five national standards of 

TCM have been issued in succession, namely, Classification 

and Codes of Diseases and ZHENG of Traditional Chinese 

Medicine (GB/T15657-1995) as China’s first national 
standard for clas- sification of TCM diseases stipulates the 

classification prin- ciples and coding methods of diseases and 

ZHENG of TCM and has the corresponding computer 

software, promoting the standardization of TCM clinical 

diagnosis; Clinic Terminol- ogy of Traditional Chinese 

Medical Diagnosis and Treatment- Diseases (GB/T 16751.1-

1997), Clinic Terminology of Tradi- tional Chinese Medical 

Diagnosis and Treatment-Syndromes (GB/T 16751.2-1997), 

and Clinic Terminology of Traditional Chinese Medical 
Diagnosis and Treatment-Therapeutic Meth- ods (GB/T 

16751.3-1997) specify the basic terminology of c An essential 

document for the preservation and advancement of traditional 

Chinese medicine (TCM), the Basic Theory Terminology of 

Traditional Chinese Medicine (GB/T 20348-2006) defines key 

terms used in TCM theories including Yin and Yang, the five 

elements, and main and collateral channels. This standard is 

vital for various aspects of TCM, including but not limited to: 

teaching, research, healthcare, management, and international 

exchange [10].  
 

Where Things Stand with the Chinese TCM Technical 

Standards: A Status Report 2.3. Applying TCM in a clinical 

setting requires both medical knowledge and the theoretical 

framework of TCM. Academic societies within TCM have 

released more than 50 technical specifications between the 

years of 1980 and 2002, and TCM authorities have released 

nearly 70 technical standards, including the Clinical 

Guidelines for Emergency Treatment of Internal Medicine of 

Traditional Chinese Medicine (YY228) and Criteria of 

Diagnosis and Therapeutic Effect of Diseases and Syndromes 

in TCM (ZY/T001.1-94) [6]. We have made significant 

progress in standardizing the TCM industry in China with the 

first industry standard, Criteria of Diagnosis and Therapeutic 
Effect of Diseases and Syndromes in TCM. This standard 

covers nine clinical departments and forty-six diseases and 

syndromes, including internal medicine, surgery, gynecology, 

and pediatrics. 

After 2002, the formulation of industry technical stan- 

dards was further strengthened, prevention and treatment of 

common diseases and major diseases were mainly focused on 

and diagnostic and treatment guidelines for clinical syndromes 

in TCM, and operation regulation of TCM clinic technology 

and others were formulated and revised as the priority. 
Completed standards by the State Administration of 

Traditional Chinese Medicine include 18 standards for 
the series of Routine and Technical Operation Regulation of 

Nursing Care in TCM (ZYYXH/T 1.1-2006∼ZYYXH/T 1.18- 

2006) for nursing care of clinical departments such as internal 
medicine, surgery, gynecology, and pediatrics, 19 standards for 
the series of Technical Specification of Health Preservation and 

Prevention of Chinese Medicine (ZYYXH/T 158-2010∼ 

ZYYXH/T 176-2010) with massage on the spine, the whole 
body, pediatrics and moxibustion, medicinal liquor, acupoint 

sticking, cupping, and so on to guide and standardize techni- cal 

operations of TCM health care of care physicians and tech- 

nicians and make technical operations more standardized and 

more safe, 1 standard of Classification and Determination of 

Constitution in TCM (ZYYXH/T 157-2009) as the impor- tant 

reference basis for the clinical practice, to determine the 

specification and quality evaluation, 10 standards for the series 

of Standard Specifications for Study and Compilation of 

Traditional Chinese Medicine Classics (ZYYXH/T 362- 
2012∼ZYYXH/T 371-2012) for proofreading TCM classics, 1 

standard of Clinical Guidelines of Chinese Medicine on Sub- 
Health (ZYYXH/T 2-2006) for clarifying the understanding of 

subhealth of TCM, common syndromes, and interven- tion 

principles of TCM on subhealth to gain the scientific, 

standardized diagnosis and intervention on subhealth and 

provide evidences for the feasible health management plan and 

intervention measures on subhealth [11], 15 standards for the 

series of Guidelines for TCM Diabetes Prevention 
and Treatment (ZYYXH/T 3.1-2007∼ZYYXH/T 3.15-2007) for 

the course, complications, and merged diseases of diabetes 

to have detailed and normative prevention and treatment 
strategy of TCM, achieving the standardized, scientific pre- 
vention and treatment of TCM of diabetes [12], 21 standards for 
the series of Guideline for Diagnosis and Treatment of Tumor 

in TCM (ZYYXH/T 136-2008∼ZYYXH/T 156-2008) 

for the standard of differentiation of syndromes and signs 

for classification and diagnosis and treatment of TCM of 



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common malignant tumor (according to preliminary clinical 
statistics, 70–80% of cancer patients accepted the different levels 

of TCM treatments; Chinese medicine tumor has become an 
important part of modern Chinese medicine clin- ical disciplines; 
this “guideline” can improve the overall level of TCM prevention 
and treatment of malignant tumor [13]), and 386 standards for the 
series of Guideline for Diagnosis and Treatment of Common 
Diseases in TCM. In total, 397 diseases of 11 clinical majors were 

involved such as internal medicine, surgery, gynecology, 
pediatrics, ophthalmology, ENT, anorectal section, dermatology, 
and orthopedics, and the most common TCM clinical diseases 
were covered [9]. Three systems, namely, technical specification 
for clinical diagnosis and treatment of common TCM diseases, 
health care technology, and nursing care, have been formulated and 

the criteria for clinical diagnosis and treatment in TCM are further 
enriched. 

2.1. Current Status of the Formulation and Revision of TCM 
Management Standards in China. TCM management stan- dards 
are formulated to regulate the TCM industry and con- trol matters 
required for uniform coordination in the man- agement practice. 

The State Administration of Traditional Chinese Medi- cine 
has combined with relevant departments to issue many 

management standards related to construction of traditional 
Chinese hospitals, construction of major TCM laboratories, 
classification of TCM research laboratories, TCM education 
management, and others [14] and covered TCM treatment, 
scientific research, education, and other fields, thereby laying 
foundation for the construction of TCM standard system. 

In summary, 5 national TCM standards and over 480 TCM 
industrial standards have been formulated and issued for 
implementation and the TCM standard system is pri- marily 
established, which ensures the standardization of TCM 
development smoothly, and improves the standard for formulation 
and revision work. See the publication situations of current TCM 

standards in Table 1. 

2.2. TCM Standardization Support System Has Been Basically 
Established. The support system is to promote and guarantee TCM 
standards, including management system, operation system, 
technical platform, professional team, implementa- tion and 
guarantee, inspection and evaluation, and informa- tion service. 

2.3. TCM Standardization Management System and Operation 
Mechanism Have Been Primarily Established. TCM Stan- 

dardization Management Department of China Administra- tion of 
Traditional Medicine is responsible for centralized management 

and coordinated planning of TCM standard- ization. The 
standardization office is specially built as the routine 
administrative office for TCM standardization to fully coordinate 
the standardization of the industry. 

Several TCM standardization technology research cen- ters 
have been established across the country to strengthen the 
organizational management on formulation, implemen- tation, and 
supervision of TCM standards [15]. In Septem- ber 2010, China 
Administration of Traditional Medicine 

 
confirmed 42 base (pilot) construction units for TCM stan- 
dardization research and promotion so as to provide a strong 
guarantee for implementation and promotion of TCM standards. 
China Administration of Traditional Medicine has released TCM 
Standard Formulation Procedure and Interim Measures of State 
Administration of Traditional Medicine on Management of TCM 
Standardization Project, in which the formulation and 
management procedure of TCM standards have been regulated 
[16]. 

2.4. TCM Standardization Technology Team Has Been Basically 
Formed. Talents are essential to promote the TCM standardi- zation. 
With the constant establishment of TCM standardiza- tion research 
institutes and academic communities, the TCM standardization 
talent team is gradually expanding from scratch. 

In 2006, the first National TCM Standardization Training Class 

was held in Wuhan and attracted over 120 TCM profes- sional 
participants across the country in the technical train- ing; in 2008, 
China Administration of Traditional Medicine established the pilot 
construction unit of “Acupuncture and Moxibustion Research 
Center of China Administration of Traditional Medicine” in Tianjin 
University of Traditional Chi- nese Medicine and “TCM Technical 

Training and Research Center of China Administration of 
Traditional Medicine in Hubei University of Traditional Chinese 
Medicine,” thereby providing important intelligent support and 
sufficient guar- antee for implementation of TCM standardization 
develop- ment plan; and by 2009, over 800 researchers and 
experts participated in standardization projects, initially forming 
the TCM standardization team of a certain size [17]. 

2.5. Actively Participate in TCM International Standardiza- tion. 
In 2003, the World Federation of Chinese Medicine Societies was 
established and headquartered in Beijing. It enhanced the 
formulation, publicity, and promotion of TCM international 
standards. In 2007, WHO issued International Standard 

Terminologies on Traditional Medicine, which was prepared in 
corroboration by personnel from China, Korea, Japan, and other 
countries. 

In September 2009, International Organization for Stan- 
dardization (ISO) established Committee of TCM Standard- ization 
Technology with the code of ISO/TC249 (tentatively) [18]. In 

ISO/TC249, a total of 44 standard projects have been put forward 
since 2011, including 29 projects by China [19]. 

Upon the revision of Codes of International Classification of 
Diseases (ICD-11), WHO has decided to include the traditional 
medicine, and China has actively participated in the preparation of 
traditional medicine. All of the works lay an important milestone 

for the international standardization of TCM and also are the 
important opportunities for China to regain the initiative in the 
international standardization. 

3. Problems and Some Countermeasures of the 
Construction of TCM 

Standardization in China 

Since 1980s, the constant exploration on the standardization of 
Traditional Chinese Medicine (TCM) has made certain 



14   

 

supervision bureau 

Sub-Health 

and Treatment 

 

 

 

 

 

TABLE 1: The existing standards of Traditional Chinese Medicine in China (a total of 486). 

Serial number Standard number Standard title Issuance date Execution date Release unit 

Classification and Codes of Diseases and 

ZHENG of Traditional Chinese Medicine 

Clinic Terminology of Traditional Chinese 

25 July 1995 1 January 1996 AQSIQ; SAC 

 

 National standard (a total of 5) 

2 GB/T 16751.1-1997 Medical Diagnosis and 

Treatment-Diseases 
Clinic Terminology of Traditional Chinese 

4 March 1997 1 October 1997 AQSIQ; SAC 

 
Chinese technical 

3 GB/T 16751.2-1997 

 

 

4 GB/T 16751.3-1997 

Medical Diagnosis and 

Treatment-Syndromes 

Clinic Terminology of Traditional Chinese 

Medical Diagnosis and 
Treatment-Therapeutic Methods 

4 March 1997 1 October 1997 

 

 

4 March 1997 1 October 1997 

supervision bureau 

 

Chinese technical 

supervision bureau 

Basic Theory Terminology of Traditional 

Chinese Medicine 

Clinical Guidelines for Emergency 

25 May 2006 1 October 2006 
Chinese technical 

6 YY228 Treatment of Internal Medicine of 

Traditional Chinese Medicine 
1 March 1994 1 March 1994 SATCM 

 

 

 

 

 

 

Industry standard (a total of 481) 

Criteria of Diagnosis and Therapeutic 

Effect of Diseases and Syndromes in TCM 

8 ZYYXH/T 2-2006 
Clinical Guidelines of Chinese Medicine on 

Routine and Technical Operation 

Regulation of Nursing Care in TCM 

10 ZYYXH/T3.1∼3.15-2007 
Guideline for TCM Diabetes Prevention 

Guidelines for Diagnosis and Treatment of 

11 ZYYXH/T4∼49-2008 

 

12 ZYYXH/T50∼135-2008 

Common Internal Diseases in Chinese 

Medicine Symptoms in Chinese Medicine 

Guidelines for Diagnosis and Treatment of 

Common Internal Diseases in Chinese 

Medicine Diseases of Modern Medicine 

22 July 2008 22 July 2008 CACM 

 

 

22 July 2008 22 July 2008 CACM 

Guidelines for Diagnosis and Treatment of 

Tumor in Traditional Chinese Medicine 
30 November 2008 1 December 2008 CACM 

 

4
 

1 GB/T15657-1995 

5 GB/T 20348-2006 

7 ZY/T001.1-94 

9 ZYYXH/T1.1∼1.18-2006 

13 ZYYXH/T136∼156-2008 

11 October 1994 1 January 1995 SATCM 

10 December 2006 10 December 2006 CACM 

25 December 2006 25 December 2006 CACM 

28 July 2007 28 July 2007 CACM 

 



15   

 

 

 

TABLE 1: Continued. 

Serial number Standard number Standard title Issuance date Execution date Release unit 

Classification and Determination of 

Constitution in TCM 
Technical Specification of Health 

26 March 2009 9 April 2009 CACM 

15 ZYYXHT158∼176-2010 

 

16 ZYYXH/T177∼202-2012 

 

17 ZYYXH/T203∼246-2012 

 

18 ZYYXH/T247∼286-2012 

 

19 ZYYXH/T287∼306-2012 

 

20 ZYYXH/T307∼321-2012 

 

21 ZYYXH/T322∼341-2012 

 

22 ZYYXH/T342∼361-2012 

 

23 ZYYXH/T362∼371-2012 

 

 

24 ZYYXH/T372∼415-2012 

 

 

25 ZYYXH/T417∼441-2012 

Preservation and Prevention of Chinese 

Medicine 

Guidelines for Diagnosis and Treatment of 

Common Diseases of Surgery in 

Traditional Chinese Medicine 

Guidelines for Diagnosis and Treatment of 

Common Diseases of Gynecology in 

Traditional Chinese Medicine 

Guidelines for Diagnosis and Treatment of 

Common Diseases of Pediatric in 

Traditional Chinese Medicine 

Guidelines for Diagnosis and Treatment of 

Common Diseases of Otolaryngology in 

Traditional Chinese Medicine 

Guidelines for Diagnosis and Treatment of 

Common Diseases of Otolaryngology in 

Traditional Chinese Medicine 

Guidelines for Diagnosis and Treatment of 

Common Diseases of Coloproctology in 

Traditional Chinese Medicine 

Guidelines for Diagnosis and Treatment of 

Common Diseases of Dermatology in 

Traditional Chinese Medicine 

Standard Specification for Study and 

Compilation of Traditional Chinese 

Medicine Classics 

Guidelines for Diagnosis and Treatment of 

Common Diseases of Orthopedics and 

Traumatology in Traditional Chinese 

Medicine 

Guidelines for Diagnosis and Treatment of 

Common Diseases of Spinal Orthopedics 

in Traditional Chinese Medicine 

23 December 2010 11 January 2011 CACM 

 

 

1 July 2012 1 August 2012 CACM 

 

 

1 July 2012 1 August 2012 CACM 

 

 

1 July 2012 1 August 2012 CACM 

 

 

1 July 2012 1 August 2012 CACM 

 

 

1 July 2012 1 August 2012 CACM 

 

 

1 July 2012 1 August 2012 CACM 

 

 

1 July 2012 1 August 2012 CACM 

 

 

1 July 2012 1 August 2012 CACM 

 

 

1 July 2012 1 August 2012 CACM 

 

 

1 July 2012 1 August 2012 CACM 

AQSIQ, General Administration of Quality Supervision, Inspection, and Quarantine of the People’s Republic of China; SAC, Standardization Administration of the People’s Republic of China; SATCM, State 

Administration of Traditional Chinese Medicine of the People’s Republic of China; CACM, China Association of Chinese Medicine. 

5
 

14 ZYYXH/T157-2009 



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achievements. However, on account of its long-term, arduous, 

and complex nature, the current TCM standardization still 
falls behind with the developmental needs of TCM. 

It is necessary to reinforce awareness of TCM standardization 

(3.1). Many TCM practitioners still have a lack of awareness 

and different ideas about TCM standardization, which makes 

them feel unprepared, unmotivated, and responsible for the 

lack of progress in this area [20]. This is because TCM 

standardization is still in its early stages and has not yet been 

adequately publicized or implemented. To prepare for the 

eventual adoption of TCM standardization, it is imperative 

that we raise awareness among TCM practitioners via 

increased education and publicity about the need of 

synchronization between clinical practice and classroom 

instruction [21, 22].  

There is a need to improve the TCM standardization system 

(3.2). Currently, published standards only address the basics 

of TCM, focusing on its basis and functioning rather than 

delving into all of its aspects. It is critically important to 

update and reinforce standards in health care, research, 

education, information, particularly management, and other 

areas of TCM in light of the international recognition that has 

been bestowed upon the incorporation of seven TCM clinical 

trials into clinical trials for eleven different types of 

gynecology diseases [23]. As a result, the whole TCM 

standardized system will be enriched and improved via the 

creation of balanced quantity, quality, structure, and benefit 

[24].  

3.3.1 The Methods for TCM Standardization Requirements 

Must Be Fulfilled. There is a paucity of evidence-based 

medicine and clinical evidence that supports many of the 

current standardizations, which makes it difficult to use them 

in clinical practice [25]. Additionally, the "aging" of TCM 

standardization is caused by a flawed revision mechanism 

[20]. Clinic Terms of Traditional Chinese Medicine, for 

example, has remained unchanged since its release in 1997 

and is currently the only national standard in the field. This 

means that TCM standards aren't up-to-date enough to match 

the current academic level and managerial needs of TCM, 

which renders them irrelevant and slows down their adoption 

and use [26].  

In this case, TCM standardization may benefit from enhanced 

methodological study into the standard revision in order to 

find a redaction approach that works for TCM's unique 

characteristics.  

3.4. Standardize Traditional Chinese Medicine's Support 

System. There has been tremendous increase in the 

development of TCM standards, but there has been very little 

progress in the associated support system, which is still in its 

early stages and needs more refinement. There is a lack of 

qualified individuals working in traditional Chinese medicine 

(TCM), and there is a lack of completion in the TCM 

standardized system's administration, implementation, and 

oversight [16]. Surveys and feedbacks on the system's 

applicability are also lacking. Traditional Chinese Medicine's 

State Administration released  

 

a more thorough and organized development of the support 

system for TCM standardization is guaranteed to occur under 

the supervision of the Guidance on Strengthening the 

Standardization of Traditional Chinese Medicine.  

 

3.5. Promptly Support the Global Standardization of 

Traditional Chinese Medicine (TCM). At the current time, 

there are very few worldwide TCM standards, and the 

majority of them are domestic. Furthermore, China should 

make the most of its position as a permanent member of the 

international standardization organization and its 

involvement in the secretariat of the TCM technical committee 

in order to actively participate in the establishment of 

development strategies, regulations, and projects related to 

TCM standardization. It is also important to take advantage 

of China's dominance in TCM international standardization 

to encourage the transition of TCM standards to international 

ones [27].  

There is a steady march toward TCM standardization, which 

includes new developments in the field and advancements in 

academia. It is important to promote standardization under a 

comprehensive plan and top design and to continue with 

staged and planned measures because of the basic, strategic, 

and worldwide implications it will have on the development of 

TCM [28]. We are hopeful that the newly released Medium- 

and Long-Term Development Plan on the Standardization of 

Traditional Chinese Medicine (2011-2020) would lead to a 

more methodical and scientific advancement of TCM 

standardization for the benefit of people's health. 

 

 

Acknowledgments 

This work was supported by the State Administration of 

Traditional Chinese Medicine [ZYYS-2011-(0033)-1] and 
National Natural 90 Science Foundation of China (Grant no. 

81330088) and National Key Technology Support Program 

(no. 2012BAI25B03). 

 

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