Review Article Current Status of Standardization of

Review ArticleCurrent Status of Standardization of Traditional ChineseMedicine in China

Juan Wang,1,2 Yi Guo,2,3 and Gui Lan Li1,2

1Baokang Hospital, Tianjin University of Traditional Chinese Medicine, No. 88, Yuquan Road, Nankai District, Tianjin 300193, China2Plot Construction Unit of Acupuncture and Moxibustion and Standardization Research Center of State Administration ofTraditional Chinese Medicine, Tianjin 300193, China3Acupuncture and Moxibustion College, Tianjin University of Traditional Chinese Medicine, No. 312, Anshan West Road,Nankai District, Tianjin 300193, China

Correspondence should be addressed to Yi Guo; guoyi [email protected]

Received 16 October 2015; Revised 2 February 2016; Accepted 3 March 2016

Academic Editor: Xiu-Min Li

Copyright © 2016 Juan Wang et al. This is an open access article distributed under the Creative Commons Attribution License,which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

As an important component of traditional medicine, Traditional Chinese Medicine (TCM) is widely spread and applied in morethan 100 countries across the world. The standardization of TCM is very important for the international application of Chinesemedicine. In this paper, we have explained and analyzed the standardization situations of TCM in China with the purpose ofproviding reference for standardization and international development of TCM.

1. Introduction

TCM has been widely applied to prevention and treatmentfor various diseases from ancient times till now [1]. TCM,a natural therapy, is safe, effective, and widely used and isincreasingly attracting worldwide attention [2]. WHO Tra-ditional Medicine Strategy: 2014–2023 released by the WorldHealth Organization shows that TCM has spread to morethan 100 countries and has grown into an international indus-try [3]. However, due to the lack of relevant standards, thedevelopment of TCM is undermined and the progress ofinternationalization and modernization of TCM is seriouslyinfluenced [4, 5].

As the country of origin and application of TCM, Chinahas a unique TCM theoretic system and effective treatmentmethods. In recent years, after the constant transformation ofconcepts and methods, great breakthroughs and remarkableachievements have been made in terms of standardizationof TCM, but some problems remain [6]. In this paper, wemainly focus on summary and analysis on research of currentsituations in standardization of TCM (excluding acupunctureand moxibustion and traditional Chinese herbs) [7].

2. Current Status of Standardization ofTraditional Chinese Medicine in China

2.1. China Attaches Great Importance to Standardization ofTCM. Standardization of TCM, under the principle of “uni-fication, simplification, coordination, and optimization” andby its comprehensive use, refers to developing and applyingstandards to the various links, processes, and objects of TCMsuch as medical care, scientific research, education, industry,culture, andmanagement, to promote academic developmentand propagation of achievement of TCM, to standardizemanagement of TCM, to guarantee the quality and safetyof TCM, to promote the modernization and internationalcommunication of TCM so as to achieve good economicand social benefits, and to achieve guiding and supportinga series of activities for the purpose of the comprehensivedevelopment of TCM [8]. Standardization of TCM is anessential part of themodernization of TCM. In 2009, the StateCouncil of China issued Several Opinions of the State Councilon Supporting and Promoting the Development of TraditionalChinese Medicine, in which “promoting the standardizationof TCM” was included.

Hindawi Publishing CorporationEvidence-Based Complementary and Alternative MedicineVolume 2016, Article ID 9123103, 7 pageshttp://dx.doi.org/10.1155/2016/9123103

2 Evidence-Based Complementary and Alternative Medicine

In the National Work Conference on Traditional ChineseMedicine convened in 2011, Comrade Li Keqiang, a memberof Central Politburo Standing Committee of the CommunistParty of China andVice Premier of the State Council, stressedthat “the construction for the standardization of TCM shouldbe strengthened.”

In the Twelfth Five-Year Planning Outline for NationalEconomic and Social Development of the People’s Republic ofChina, National Development and Reform Commission hasincluded “promotion of standardization and normalization ofTCM” as one of the important tasks. Ministry of Science andTechnology took the lead to formulate Traditional ChineseMedicine Innovation Development Planning Outline 2006–2020, in which the standardization of TCM was set as onepriority area for being the standard specifications of theinternational traditional medicine. Standardization Admin-istration of the People’s Republic of China will support theTCM as an important field for international breakthroughand arrange almost hundreds of standard items of TCM inthe service standard development plan.

2.2. Standard System of TCM Has Been Basically Establishedin China. During the “Eleventh Five-Year Plan” period, theTCM standard system has been basically established. Thesystem consists of four categories of standards, namely, basicstandards, technical standards, management standards, andworking standards [9], and formulation and revision of basicstandards and technical standards were stressed.

2.3. Current Status of the Formulation and Revision of TCMBasic Standards in China. The formulation of basic and gen-eral standards of Traditional Chinese Medicine started withthe focus on formulation and revision for basic theoreticalterminology, terminology of some subjects of TCM and theirclassification and codes, and other standards to achieve TCMterminology standardization. Five national standards of TCMhave been issued in succession, namely, Classification andCodes ofDiseases andZHENGof Traditional ChineseMedicine(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 TCMand has the corresponding computer software, promoting thestandardization 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 TraditionalChinese Medical Diagnosis and Treatment-Therapeutic Meth-ods (GB/T 16751.3-1997) specify the basic terminology ofcommon diseases, syndromes, and therapeutic principles ofTCM to improve the medical quality of TCM and the level ofscientific management of medical institutions of TCM posi-tive role and Basic Theory Terminology of Traditional ChineseMedicine (GB/T 20348-2006) provides the basic standard forthe terminology of TCM theories such as Yin and Yang, fiveelements, and main and collateral channels, which is of greatsignificance for the inheritance and innovation of TCM andmeeting the needs of the teaching, scientific research, healthcare, management, and foreign exchange of TCM [10].

2.4. Current Status of the Formulation and Revision of TCMTechnical Standards in China. The clinical practice of TCMneeds not only the guidance of TCM theory but the tools ofmedical treatment. From the 1980s to 2002, TCM authoritieshave issued nearly 70 technical standards such as Criteria ofDiagnosis and Therapeutic Effect of Diseases and Syndromesin TCM (ZY/T001.1-94) and Clinical Guidelines for Emer-gency Treatment of Internal Medicine of Traditional ChineseMedicine (YY228), and TCM academic societies have issuedover 50 technical specifications [6]. Criteria of Diagnosis andTherapeutic Effect of Diseases and Syndromes in TCM is thefirst industry standard of TCM in China for 9 clinical depart-ments with 406 diseases and syndromes, including internalmedicine, surgery, gynecology, and pediatrics, marking thatthe major progress was made in the standardization of TCMindustry in China.

After 2002, the formulation of industry technical stan-dards was further strengthened, prevention and treatment ofcommon diseases and major diseases were mainly focusedon and diagnostic and treatment guidelines for clinicalsyndromes in TCM, and operation regulation of TCM clinictechnology and others were formulated and revised as thepriority. Completed standards by the State Administrationof Traditional Chinese Medicine include 18 standards forthe series of Routine and Technical Operation Regulation ofNursing Care in TCM (ZYYXH/T 1.1-2006∼ZYYXH/T 1.18-2006) for nursing care of clinical departments such as internalmedicine, surgery, gynecology, and pediatrics, 19 standardsfor the series of Technical Specification of Health Preservationand Prevention of Chinese Medicine (ZYYXH/T 158-2010∼ZYYXH/T 176-2010) with massage on the spine, the wholebody, pediatrics andmoxibustion, medicinal liquor, acupointsticking, cupping, and so on to guide and standardize techni-cal operations of TCMhealth care of care physicians and tech-nicians and make technical operations more standardizedand more safe, 1 standard of Classification and Determinationof Constitution in TCM (ZYYXH/T 157-2009) as the impor-tant reference basis for the clinical practice, to determinethe specification and quality evaluation, 10 standards for theseries of Standard Specifications for Study and Compilationof Traditional Chinese Medicine Classics (ZYYXH/T 362-2012∼ZYYXH/T 371-2012) for proofreading TCM classics, 1standard of Clinical Guidelines of Chinese Medicine on Sub-Health (ZYYXH/T 2-2006) for clarifying the understandingof subhealth of TCM, common syndromes, and interven-tion principles of TCM on subhealth to gain the scientific,standardized diagnosis and intervention on subhealth andprovide evidences for the feasible health management planand intervention measures on subhealth [11], 15 standardsfor the series of Guidelines for TCM Diabetes Preventionand Treatment (ZYYXH/T 3.1-2007∼ZYYXH/T 3.15-2007)for the course, complications, andmerged diseases of diabetesto have detailed and normative prevention and treatmentstrategy of TCM, achieving the standardized, scientific pre-vention and treatment of TCM of diabetes [12], 21 standardsfor the series of Guideline for Diagnosis and Treatment ofTumor in TCM (ZYYXH/T 136-2008∼ZYYXH/T 156-2008)for the standard of differentiation of syndromes and signsfor classification and diagnosis and treatment of TCM of

Evidence-Based Complementary and Alternative Medicine 3

commonmalignant tumor (according to preliminary clinicalstatistics, 70–80% of cancer patients accepted the differentlevels of TCM treatments; Chinese medicine tumor hasbecome an important part of modern Chinese medicine clin-ical disciplines; this “guideline” can improve the overall levelof TCM prevention and treatment of malignant tumor [13]),and 386 standards for the series of Guideline for Diagnosisand Treatment of Common Diseases in TCM. In total, 397diseases of 11 clinical majors were involved such as internalmedicine, surgery, gynecology, pediatrics, ophthalmology,ENT, anorectal section, dermatology, and orthopedics, andthe most common TCM clinical diseases were covered [9].Three systems, namely, technical specification for clinicaldiagnosis and treatment of common TCM diseases, healthcare technology, and nursing care, have been formulated andthe criteria for clinical diagnosis and treatment in TCM arefurther enriched.

2.5. Current Status of the Formulation and Revision of TCMManagement 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 manymanagement standards related to construction of traditionalChinese hospitals, construction of major TCM laboratories,classification of TCM research laboratories, TCM educationmanagement, and others [14] and covered TCM treatment,scientific research, education, and other fields, thereby layingfoundation for the construction of TCM standard system.

In summary, 5 national TCM standards and over 480TCM industrial standards have been formulated and issuedfor implementation and the TCM standard system is pri-marily established, which ensures the standardization ofTCM development smoothly, and improves the standard forformulation and revision work. See the publication situationsof current TCM standards in Table 1.

2.6. TCM Standardization Support System Has Been BasicallyEstablished. The support system is to promote and guaranteeTCM standards, including management system, operationsystem, technical platform, professional team, implementa-tion and guarantee, inspection and evaluation, and informa-tion service.

2.7. TCM StandardizationManagement System andOperationMechanism Have Been Primarily Established. TCM Stan-dardization Management Department of China Administra-tion of Traditional Medicine is responsible for centralizedmanagement and coordinated planning of TCM standard-ization. The standardization office is specially built as theroutine administrative office for TCMstandardization to fullycoordinate the standardization of the industry.

Several TCM standardization technology research cen-ters have been established across the country to strengthenthe 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 astrong guarantee for implementation and promotion of TCMstandards. China Administration of TraditionalMedicine hasreleased TCM Standard Formulation Procedure and InterimMeasures of State Administration of Traditional Medicine onManagement of TCM Standardization Project, in which theformulation and management procedure of TCM standardshave been regulated [16].

2.8. TCM Standardization Technology TeamHas Been BasicallyFormed. Talents are essential to promote the TCM standardi-zation. With the constant establishment of TCM standardiza-tion research institutes and academic communities, the TCMstandardization talent team is gradually expanding fromscratch.

In 2006, the first National TCM Standardization TrainingClass was held inWuhan and attracted over 120 TCM profes-sional participants across the country in the technical train-ing; in 2008, China Administration of Traditional Medicineestablished the pilot construction unit of “Acupuncture andMoxibustion Research Center of China Administration ofTraditional Medicine” in Tianjin University of Traditional Chi-nese Medicine and “TCM Technical Training and ResearchCenter of China Administration of Traditional Medicine inHubei University of Traditional Chinese Medicine,” therebyproviding important intelligent support and sufficient guar-antee for implementation of TCM standardization develop-ment plan; and by 2009, over 800 researchers and expertsparticipated in standardization projects, initially forming theTCM standardization team of a certain size [17].

2.9. Actively Participate in TCM International Standardiza-tion. In 2003, the World Federation of Chinese MedicineSocieties was established and headquartered in Beijing. Itenhanced the formulation, publicity, and promotion of TCMinternational standards. In 2007, WHO issued InternationalStandard Terminologies on Traditional Medicine, which wasprepared 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 beenput forward since 2011, including 29 projects by China [19].

Upon the revision of Codes of International Classificationof Diseases (ICD-11), WHO has decided to include thetraditional medicine, and China has actively participated inthe preparation of traditional medicine. All of the works layan important milestone for the international standardizationof TCM and also are the important opportunities for Chinato regain the initiative in the international standardization.

3. Problems and Some Countermeasures ofthe Construction of TCMStandardization in China

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


Table1:Th

eexistingsta

ndards

ofTradition

alCh

ineseM

edicineinCh

ina(

atotalof

486).

Seria

lnum

ber

Standard

number

Standard

title

Issuance

date

Executiondate

Releaseu

nit

Nationalstand

ard(a

totalof5)

1GB/T15657-1995

Classifi

catio

nan

dCo

deso

fDise

asesan

dZH

ENGofTraditionalCh

ineseM

edicine

25July1995

1January

1996

AQSIQ;SAC

2GB/T16751.1-1997

ClinicTerm

inologyo

fTraditio

nalC

hinese

Medica

lDiagnosisand

Treatm

ent-D

iseases

4March

1997

1Octob

er1997

AQSIQ;SAC

3GB/T16751.2

-1997

ClinicTerm

inologyo

fTraditio

nalC

hinese

Medica

lDiagnosisand

Treatm

ent-S

yndrom

es4March

1997

1Octob

er1997

Chinesetechn

ical

supervision

bureau

4GB/T16751.3

-1997

ClinicTerm

inologyo

fTraditio

nalC

hinese

Medica

lDiagnosisand

Treatm

ent-Th

erapeutic

Methods

4March

1997

1Octob

er1997

Chinesetechn

ical

supervision

bureau

5GB/T20348-2006

Basic

Theory

Term

inologyo

fTraditio

nal

ChineseM

edicine

25May

2006

1Octob

er2006

Chinesetechn

ical

supervision

bureau

Indu

strysta

ndard(a

totalof4

81)

6YY

228

Clinica

lGuidelin

esforE

mergency

Treatm

entofInterna

lMedicine

ofTraditionalCh

ineseM

edicine

1March

1994

1March

1994

SATC

M

7ZY

/T001.1-94

Criteria

ofDiagnosisan

dTh

erapeutic

EffectofD

iseasesandSynd

romesin

TCM

11Octob

er1994

1January

1995

SATC

M

8ZY

YXH/T

2-2006

Clinica

lGuidelin

esofCh

ineseM

edicine

onSub-Health

10Decem

ber2

006

10Decem

ber2

006

CACM

9ZY

YXH/T1.1∼1.18-2006

Routinea

ndTechnicalO

peratio

nRegulatio

nofNu

rsingC

areinTC

M25

Decem

ber2

006

25Decem

ber2

006

CACM

10ZY

YXH/T3.1∼3.15-2007

Guideline

forT

CMDiabetesP

revention

andTreatm

ent

28July2007

28July2007

CACM

11ZY

YXH/T4∼

49-2008

Guidelinesfor

DiagnosisandTreatm

entof

Common

InternalDise

asesin

Chinese

Medicine

Symptom

sinCh

ineseM

edicine

22July2008

22July2008

CACM

12ZY

YXH/T50∼135-2008

Guidelinesfor

DiagnosisandTreatm

entof

Common

InternalDise

asesin

Chinese

Medicine

Dise

asesofModernMedicine

22July2008

22July2008

CACM

13ZY

YXH/T136∼

156-2008

Guidelinesfor

DiagnosisandTreatm

entof

Tumor

inTraditionalCh

ineseM

edicine

30Novem

ber2

008

1Decem

ber2

008

CACM


Table1:Con

tinued.

Seria

lnum

ber

Standard

number

Standard

title

Issuance

date

Executiondate

Releaseu

nit

14ZY

YXH/T157-2009

Classifi

catio

nan

dDeterminationof

Constitutionin

TCM

26March

2009

9Ap

ril2009

CACM

15ZY

YXHT158∼176-2010

TechnicalSpecifi

catio

nofHealth

Preservatio

nandPreventio

nofCh

inese

Medicine

23Decem

ber2

010

11Janu

ary2011

CACM

16ZY

YXH/T177∼

202-2012

Guidelinesfor

DiagnosisandTreatm

entof

Common

Dise

asesofSurgeryin

TraditionalCh

ineseM

edicine

1July2012

1August2

012

CACM

17ZY

YXH/T203∼

246-2012

Guidelinesfor

DiagnosisandTreatm

entof

Common

Dise

asesofGy

necology

inTraditionalCh

ineseM

edicine

1July2012

1August2

012

CACM

18ZY

YXH/T247∼

286-2012

Guidelinesfor

DiagnosisandTreatm

entof

Common

Dise

asesofPediatric

inTraditionalCh

ineseM

edicine

1July2012

1August2

012

CACM

19ZY

YXH/T287∼

306-2012

Guidelinesfor

DiagnosisandTreatm

entof

Common

Dise

asesofOtolaryngologyin

TraditionalCh

ineseM

edicine

1July2012

1August2

012

CACM

20ZY

YXH/T307∼

321-2

012

Guidelinesfor

DiagnosisandTreatm

entof

Common

Dise

asesofOtolaryngologyin

TraditionalCh

ineseM

edicine

1July2012

1August2

012

CACM

21ZY

YXH/T322∼

341-2

012

Guidelinesfor

DiagnosisandTreatm

entof

Common

Dise

asesofCo

loproctology

inTraditionalCh

ineseM

edicine

1July2012

1August2

012

CACM

22ZY

YXH/T342∼

361-2

012

Guidelinesfor

DiagnosisandTreatm

entof

Common

Dise

asesofDermatologyin

TraditionalCh

ineseM

edicine

1July2012

1August2

012

CACM

23ZY

YXH/T362∼

371-2

012

Standard

Specificatio

nforS

tudy

and

Compilatio

nofTraditionalCh

inese

Medicine

Classics

1July2012

1August2

012

CACM

24ZY

YXH/T372∼

415-2012

Guidelinesfor

DiagnosisandTreatm

entof

Common

Dise

asesofOrthopedicsand

TraumatologyinTraditionalCh

inese

Medicine

1July2012

1August2

012

CACM

25ZY

YXH/T417∼

441-2

012

Guidelinesfor

DiagnosisandTreatm

entof

Common

Dise

asesofSpinalOrthopedics

inTraditionalCh

ineseM

edicine

1July2012

1August2

012

CACM

AQSIQ,G

eneral

Administratio

nof

QualitySupervision

,Inspection,

andQuarantineof

thePeop

le’sRe

public

ofCh

ina;SA

C,StandardizationAd

ministratio

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achievements.However, on account of its long-term, arduous,and complex nature, the current TCM standardization stillfalls behind with the developmental needs of TCM.

3.1. Awareness of TCM Standardization Needs to Be Rein-forced. Since TCM standardization is still in its developingphase and inadequate in publicizing and implementing, anumber of TCM practitioners still hold weak consciousnessand different cognitions towards TCM standardization, thusresulting in their infirm identity, urgency, and responsibilityfor carrying out TCM standardization [20]. Therefore, weshould enhance publicity and education of TCM standardiza-tion to improve awareness of TCM practitioners and attachgreat importance to the synchronization from the clinics tothe classrooms [21, 22] so as to pave the way for the futureimplementation of TCM standardization.

3.2. TCMStandardization SystemNeeds to Be Improved. Pub-lished standardization at present revealed limited coverage incriteria of TCM, emphasizing the foundation and operationwithout covering in all areas. The application of the latestindustry standards of seven clinical trials of TCM into clinicaltrials for 11 kinds of gynecology diseases has gained interna-tional recognition [23], which means it is very necessary tofurther revise the standards and to strengthen the standardson health care, research, education, information, especiallymanagement, and other areas of TCM. That will ensure abalanced development of the quantity, quality, structure, andbenefit which make further efforts to enrich and improve thewhole TCM standardization system [24].

3.3. Revised Methods of TCM Standardization Needs toBe Completed. Many of the present standardizations aremainly based on the literatures and lack of evidence-basedmedicine and clinical evidence,which impede their executionin clinical practice [25]. Moreover, the defective revisingprocedure gives rise to the “aging” of TCM standardization[20]. For instance, ever since the publication of the nationalstandard,Clinic Terms of Traditional ChineseMedicine in 1997,it has not yet been revised till now. As a consequence, thelagging update of standardsmakes themdetachedwith realityand thus unable to truly reflect the current academic leveland management requirements of TCM, which hinders thepopularization and application of TCM standards [26].

For the present situation, methodology researches of thestandard revision need to be improved to reach a redactionmethod suitable for its own features of TCM, which willperform a positive effect on TCM standardization.

3.4. Consolidate the Support System of TCM Standardization.Development of TCM standards is witnessing boominggrowth, while the progress of related support system iscomparatively slow, which is still in its infancy and in needof further refining. So far, the management, implementa-tion, and supervision system of TCM standardization isstill incomplete; surveys and feedbacks of its applicabilityare also imperfect; what is more, it also shows a shortageof talented professionals in such a field [16]. In 2012, theState Administration of Traditional Chinese Medicine issued

the Guidance on Strengthening the Standardization of Tra-ditional Chinese Medicine, under whose direction supportsystem of TCM standardization is bound to receive a muchmore comprehensive and orderly development.

3.5. Vigorously Advance the Process of TCM InternationalStandardization. Most of the present established TCM stan-dards are domestic, with few international ones. So it isimportant to take full advantage of China’s status as a perma-nent member of international standardization organizationas well as its working role in secretariat of TCM technicalcommittee, so as to play an active part in setting developmentstrategies, regulations, and projects of TCM standardization;besides, dominance of TCM international standardizationshould be seized in order to promote the transformation ofTCM standards to international ones [27].

The standardization of TCM is a gradual process, as wellas a course of innovation and academic progress. Because ofits fundamental, strategic, and global effects in developmentof TCM, the standardization should be promoted undera comprehensive plan and top design and proceeded withphased and planned steps [28].TheMedium- and Long-TermDevelopment Plan about the Standardization of TraditionalChinese Medicine (2011–2020) has been published, and webelieve, under its direction, there will be amore scientific andorderly development of TCM standardization for the servicesof people’s health.

Disclosure

Juan Wang, Yi Guo, and Gui Lan Li are joint first authors.

Competing Interests

The authors declare that they have no competing interests.

Acknowledgments

This work was supported by the State Administration ofTraditional Chinese Medicine [ZYYS-2011-(0033)-1] andNational Natural 90 Science Foundation of China (Grant no.81330088) and National Key Technology Support Program(no. 2012BAI25B03).

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