Current Status of Standardization of Traditional Chinese Medicine in China

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.


Introduction
TCM has been widely applied to prevention and treatment for various diseases from ancient times till now [1]. TCM, a natural therapy, is safe, effective, and widely used and is increasingly attracting worldwide attention [2]. WHO Traditional Medicine Strategy: 2014-2023 released by the World Health Organization shows that TCM has spread to more than 100 countries and has grown into an international industry [3]. However, due to the lack of relevant standards, the development of TCM is undermined and the progress of internationalization and modernization of TCM is seriously influenced [4,5].
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 [6]. In this paper, we mainly focus on summary and analysis on research of current situations in standardization of TCM (excluding acupuncture and moxibustion and traditional Chinese herbs) [7].  Outline 2006Outline -2020 in which the standardization of TCM was set as one priority area for being the standard specifications of the international traditional medicine. Standardization Administration of the People's Republic of China will support the TCM as an important field for international breakthrough and arrange almost hundreds of standard items of TCM in the service standard development plan.

Standard System of TCM Has Been Basically Established in China.
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 [9], and formulation and revision of basic standards and technical standards were stressed.

Current Status of the Formulation and Revision of TCM
Basic Standards in China. 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, Classification and Codes of Diseases and ZHENG of Traditional Chinese Medicine (GB/T15657-1995) as China's first national standard for classification of TCM diseases stipulates the classification principles and coding methods of diseases and ZHENG of TCM and has the corresponding computer software, promoting the standardization of TCM clinical diagnosis; Clinic Terminology of Traditional Chinese Medical Diagnosis and Treatment-Diseases (GB/T 16751. , Clinic Terminology of Traditional Chinese Medical Diagnosis and Treatment-Syndromes (GB/T 16751. , and Clinic Terminology of Traditional Chinese Medical Diagnosis and Treatment-Therapeutic Methods (GB/T 16751.  specify the basic terminology of common diseases, syndromes, and therapeutic principles of TCM to improve the medical quality of TCM and the level of scientific management of medical institutions of TCM positive role and Basic Theory Terminology of Traditional Chinese Medicine (GB/T 20348-2006) provides the basic standard for the terminology of TCM theories such as Yin and Yang, five elements, and main and collateral channels, which is of great significance for the inheritance and innovation of TCM and meeting the needs of the teaching, scientific research, health care, management, and foreign exchange of TCM [10].  [6]. Criteria of Diagnosis and Therapeutic Effect of Diseases and Syndromes in TCM is the first industry standard of TCM in China for 9 clinical departments with 406 diseases and syndromes, including internal medicine, surgery, gynecology, and pediatrics, marking that the major progress was made in the standardization of TCM industry in China.

Current Status of the Formulation and Revision of TCM
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 for the standard of differentiation of syndromes and signs for classification and diagnosis and treatment of TCM of 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 clinical 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.

Current Status of the Formulation and Revision of TCM Management Standards in China.
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 [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 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 1.

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, implementation and guarantee, inspection and evaluation, and information service.

TCM Standardization Management System and Operation
Mechanism Have Been Primarily Established. 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 [15].

Actively Participate in TCM International Standardization. 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 Standardization (ISO) established Committee of TCM Standardization 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.

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 4 Evidence-Based Complementary and Alternative Medicine   Evidence-Based Complementary and Alternative Medicine 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.

Awareness of TCM Standardization Needs to Be Reinforced.
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 [20]. Therefore, we should enhance publicity and education of TCM standardization to improve awareness of TCM practitioners and attach great importance to the synchronization from the clinics to the classrooms [21,22] so as to pave the way for the future implementation of TCM standardization.

TCM Standardization System
Needs to Be Improved. 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 [23], which means it is very necessary to further revise the standards and to strengthen the standards on health care, research, education, information, especially management, and other areas of TCM. That will ensure a balanced development of the quantity, quality, structure, and benefit which make further efforts to enrich and improve the whole TCM standardization system [24].

Revised Methods of TCM Standardization Needs to
Be Completed. 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 [25]. Moreover, the defective revising procedure gives rise to the "aging" of TCM standardization [20]. For instance, ever since the publication of the national standard, Clinic Terms of Traditional Chinese Medicine in 1997, it has not yet been revised till now. As a consequence, the lagging update of standards makes them detached with reality and thus unable to truly reflect the current academic level and management requirements of TCM, which hinders the popularization and application of TCM standards [26]. 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.

Consolidate the Support System of 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 [16]. In 2012, the State Administration of Traditional Chinese Medicine issued the Guidance on Strengthening the Standardization of Traditional Chinese Medicine, under whose direction support system of TCM standardization is bound to receive a much more comprehensive and orderly development.

Vigorously Advance the Process of TCM International
Standardization. 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 [27].
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 [28]. The Medium-and Long-Term Development Plan about the Standardization of Traditional Chinese Medicine (2011-2020) has been published, and we believe, under its direction, there will be a more scientific and orderly development of TCM standardization for the services of people's health.

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