As an important component of traditional medicine, Traditional Chinese Medicine (TCM) is widely spread and applied in more than 100 countries across the world. The standardization of TCM is very important for the international application of Chinese medicine. In this paper, we have explained and analyzed the standardization situations of TCM in China with the purpose of providing reference for standardization and international development of TCM.
TCM has been widely applied to prevention and treatment for various diseases from ancient times till now [
As the country of origin and application of TCM, China has a unique TCM theoretic system and effective treatment methods. In recent years, after the constant transformation of concepts and methods, great breakthroughs and remarkable achievements have been made in terms of standardization of TCM, but some problems remain [
Standardization of TCM, under the principle of “unification, simplification, coordination, and optimization” and by its comprehensive use, refers to developing and applying standards to the various links, processes, and objects of TCM such as medical care, scientific research, education, industry, culture, and management, to promote academic development and propagation of achievement of TCM, to standardize management of TCM, to guarantee the quality and safety of TCM, to promote the modernization and international communication of TCM so as to achieve good economic and social benefits, and to achieve guiding and supporting a series of activities for the purpose of the comprehensive development of TCM [
In the National Work Conference on Traditional Chinese Medicine convened in 2011, Comrade Li Keqiang, a member of Central Politburo Standing Committee of the Communist Party of China and Vice Premier of the State Council, stressed that “the construction for the standardization of TCM should be strengthened.”
In the
During the “Eleventh Five-Year Plan” period, the TCM standard system has been basically established. The system consists of four categories of standards, namely, basic standards, technical standards, management standards, and working standards [
The formulation of basic and general standards of Traditional Chinese Medicine started with the focus on formulation and revision for basic theoretical terminology, terminology of some subjects of TCM and their classification and codes, and other standards to achieve TCM terminology standardization. Five national standards of TCM have been issued in succession, namely,
The clinical practice of TCM needs not only the guidance of TCM theory but the tools of medical treatment. From the 1980s to 2002, TCM authorities have issued nearly 70 technical standards such as
After 2002, the formulation of industry technical standards 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
TCM management standards are formulated to regulate the TCM industry and control matters required for uniform coordination in the management practice.
The State Administration of Traditional Chinese Medicine 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 [
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 primarily 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
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 | |
---|---|---|---|---|---|---|
National standard (a total of 5) | 1 | GB/T15657-1995 |
|
25 July 1995 | 1 January 1996 | AQSIQ; SAC |
2 | GB/T 16751.1-1997 |
|
4 March 1997 | 1 October 1997 | AQSIQ; SAC | |
3 | GB/T 16751.2-1997 |
|
4 March 1997 | 1 October 1997 | Chinese technical supervision bureau | |
4 | GB/T 16751.3-1997 |
|
4 March 1997 | 1 October 1997 | Chinese technical supervision bureau | |
5 | GB/T 20348-2006 |
|
25 May 2006 | 1 October 2006 | Chinese technical supervision bureau | |
|
||||||
Industry standard (a total of 481) | 6 | YY228 |
|
1 March 1994 | 1 March 1994 | SATCM |
7 | ZY/T001.1-94 |
|
11 October 1994 | 1 January 1995 | SATCM | |
8 | ZYYXH/T 2-2006 |
|
10 December 2006 | 10 December 2006 | CACM | |
9 | ZYYXH/T1.1~1.18-2006 |
|
25 December 2006 | 25 December 2006 | CACM | |
10 | ZYYXH/T3.1~3.15-2007 |
|
28 July 2007 | 28 July 2007 | CACM | |
11 | ZYYXH/T4~49-2008 |
|
22 July 2008 | 22 July 2008 | CACM | |
12 | ZYYXH/T50~135-2008 |
|
22 July 2008 | 22 July 2008 | CACM | |
13 | ZYYXH/T136~156-2008 |
|
30 November 2008 | 1 December 2008 | CACM | |
14 | ZYYXH/T157-2009 |
|
26 March 2009 | 9 April 2009 | CACM | |
15 | ZYYXHT158~176-2010 |
|
23 December 2010 | 11 January 2011 | CACM | |
16 | ZYYXH/T177~202-2012 |
|
1 July 2012 | 1 August 2012 | CACM | |
17 | ZYYXH/T203~246-2012 |
|
1 July 2012 | 1 August 2012 | CACM | |
18 | ZYYXH/T247~286-2012 |
|
1 July 2012 | 1 August 2012 | CACM | |
19 | ZYYXH/T287~306-2012 |
|
1 July 2012 | 1 August 2012 | CACM | |
20 | ZYYXH/T307~321-2012 |
|
1 July 2012 | 1 August 2012 | CACM | |
21 | ZYYXH/T322~341-2012 |
|
1 July 2012 | 1 August 2012 | CACM | |
22 | ZYYXH/T342~361-2012 |
|
1 July 2012 | 1 August 2012 | CACM | |
23 | ZYYXH/T362~371-2012 |
|
1 July 2012 | 1 August 2012 | CACM | |
24 | ZYYXH/T372~415-2012 |
|
1 July 2012 | 1 August 2012 | CACM | |
25 | ZYYXH/T417~441-2012 |
|
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.
The support system is to promote and guarantee TCM standards, including management system, operation system, technical platform, professional team, implementation and guarantee, inspection and evaluation, and information service.
TCM Standardization Management Department of China Administration of Traditional Medicine is responsible for centralized management and coordinated planning of TCM standardization. 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 centers have been established across the country to strengthen the organizational management on formulation, implementation, and supervision of TCM standards [
Talents are essential to promote the TCM standardization. With the constant establishment of TCM standardization 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 professional participants across the country in the technical training; 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 Chinese 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 guarantee for implementation of TCM standardization development plan; and by 2009, over 800 researchers and experts participated in standardization projects, initially forming the TCM standardization team of a certain size [
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
In September 2009, International Organization for Standardization (ISO) established Committee of TCM Standardization Technology with the code of ISO/TC249 (tentatively) [
Upon the revision of
Since 1980s, the constant exploration on the standardization of Traditional Chinese Medicine (TCM) has made certain 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.
Since TCM standardization is still in its developing phase and inadequate in publicizing and implementing, a number of TCM practitioners still hold weak consciousness and different cognitions towards TCM standardization, thus resulting in their infirm identity, urgency, and responsibility for carrying out TCM standardization [
Published standardization at present revealed limited coverage in criteria of TCM, emphasizing the foundation and operation without covering in all areas. The application of the latest industry standards of seven clinical trials of TCM into clinical trials for 11 kinds of gynecology diseases has gained international recognition [
Many of the present standardizations are mainly based on the literatures and lack of evidence-based medicine and clinical evidence, which impede their execution in clinical practice [
For the present situation, methodology researches of the standard revision need to be improved to reach a redaction method suitable for its own features of TCM, which will perform a positive effect on TCM standardization.
Development of TCM standards is witnessing booming growth, while the progress of related support system is comparatively slow, which is still in its infancy and in need of further refining. So far, the management, implementation, and supervision system of TCM standardization is still incomplete; surveys and feedbacks of its applicability are also imperfect; what is more, it also shows a shortage of talented professionals in such a field [
Most of the present established TCM standards are domestic, with few international ones. So it is important to take full advantage of China’s status as a permanent member of international standardization organization as well as its working role in secretariat of TCM technical committee, so as to play an active part in setting development strategies, regulations, and projects of TCM standardization; besides, dominance of TCM international standardization should be seized in order to promote the transformation of TCM standards to international ones [
The standardization of TCM is a gradual process, as well as a course of innovation and academic progress. Because of its fundamental, strategic, and global effects in development of TCM, the standardization should be promoted under a comprehensive plan and top design and proceeded with phased and planned steps [
Juan Wang, Yi Guo, and Gui Lan Li are joint first authors.
The authors declare that they have no competing interests.
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).