ABSTRACT
Traditional Chinese Medicine (TCM) products could be registered as natural health products (NHPs) in Canada. Its registration process could be mainly divided into simple-application, traditional-application and non-traditional application. By analyzingi the TCM registration evidence system and its safety, effectiveness and quality required by different registration categories in Canada, we found that "simple-application" procesure needs to submit evidence based on the parameters of a component in the monograph. As for "traditional application", TCM products need to be used at least 50 years with, traditional material or Pharmacopoeia can be used as evidence; As for non-traditional application, TCM products need to provide evidence according to the disease risk level, and most of them need to provide scientific experiment evidence. Therefore, from the experience of TCM registration evidence system in Canada, the registration of TCM products should pay attention to improve the its classification method, refining its evidence requirements and data types, promoting the formulation of monograph of TCM, realizing the scientific evaluation and rapid review of classic famous prescriptions, and promoting the inheritance and innovative development of TCM in China.
ABSTRACT
At present, the registration process of Traditional Chinese Medicine (TCM) in Canada is refering to the requirements of Natural Health Products (NHPs). In terms of registration material, both NHPs and TCM include plants, animals and minerals with medicinal components, but the fundamental difference between them is that TCM is guided by the basic theory of TCM. As for the registration classification of TCM in Canada, first of all, judge whether the product to be applied for is NHPs; Secondly, we should clarify the types and ways of registration, mainly including simple application, traditional application and non-traditional application, and provide application forms, label texts, summary reports, evidence, animal tissue forms, finished product specifications and other materials according to different requirements. At present, the successful registration experience of TCM products in Canada mainly mainly includes applying for superior varieties, selecting appropriate application channels, communicating with local health management units and providing sufficient scientific evidence and good clinical application records. The regulations on the registration of NHPs in Canada have not fully considered the particularity of TCM and the registration of TCM products is still facing some difficulties. In the future, we can learn from the registration process and requirements of the Health Canada, promote the interconnection and mutual recognition of the Pharmacopoeia of the People's Republic of China and the NNHPD monographs in Canada, reduce the obstacles to the local application for registration of TCM, and promote the further improvement of the international standards of TCM.
ABSTRACT
This paper analyzes the laws, regulations and concre measures of Traditional Chinese Medicine (TCM) in Canada, so as to provide reference for TCM products to enter Canada, and for the establishment of TCM regulation system and the improvement of its detailed rules in China. The regulation of TCM in Canadian, on the one hand, supervision is to provide guidance for the protection of consumers' rights and interests, including the guidance of rational drug use and rational purchase for consumers; on the other hand, it is to supervise enterprises, including the safety, effectiveness and quality certification of TCM products, labeling and packaging requirements, as well as the site certification of product manufacturing, packaging, labeling and import. The Ministry of health of Canada takes evidence as the core of evaluation, and ensures the safe and effective use of TCM products in Canada through product and site licensing evaluation. In the supervision of TCM, relevant departments in China should further strengthen the protection of consumers' drug rights and interests, strengthen the construction of TCM registration evidence system, and pay attention to the risk management of drug production quality.
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By searching for the Canadian Licensed Natural Health Products Database, (LNHPD), this paper analyzed the characteristics and current status of 92 Chinese patent medicines successfully registered and listed in Canada, and found that the enterprises of successfully registered enterprises are mainly located in areas with better development condition of Traditional Chinese Medicine (TCM) such as Beijing, Guangdong and Tianjin; The successfully registered Chinese patent medicines include 64 kinds of single medicine or medicine with single active ingredient (69.6%) and 28 kinds of compound medicine (30.4%), the forms of the dosage are mainly tablets and capsules, which have the characteristics of accuracy in dosage and stable physicochemical properties. There are also granules, solutions, powders and other dosage forms, which can be preserved for a long time and have low requirements on technic and environment. These Chinese patent medicines are mainly used to treat respiratory and circulatory system diseases, some are used to treat urogenital and digestive system diseases, and few are used to treat difficuilt diseases like tumors, diabetes. There are some other health care products. It is suggested to strengthen the connection between domestic standards of TCM registration and international standards, and promote the scientific and technological capacity of relevant enterprises, and encourage enterprises to strengthen international registration of advantageous products, so as to accelerate the speed of international development of TCM in China.
ABSTRACT
Europe occupies an important position in the world herbal medicine market. The registration of Traditional Chinese Medicine (TCM) in EU is of great significance to the internationalization of TCM. The European Medicines Agency (EMA) has designed a relatively complete management system and regulatory guidelines for the registration and supervision of herbal medicinal products. The promulgation of the DIRECTIVE 2004/24/EC (2004 / 24 / EC) indicates that TCM could enter the EU market through simplified registration. Based on the registration conditions, registration authority and document guideines of Traditional Herbal Medicinal Products (THMPs) in EU, this paper analyzes the application requirements of simple registration of traditional herbal products in EU, and provides suggestions for the simplified registration of TCM in EU according to the registration requirements of medicinal history, quality requirements and application data format.
ABSTRACT
Thailand is a constitutional monarchy located in the central and southern part in Southeast Asia. It mainly implements the civil service insurance plan, the social insurance plan and the "Thai 30" plan, and the government bears the main health expenditures. The Thai traditional and alternative medicine system includes Thai traditional medicine, indigenous medicine and alternative medicine. Traditional Chinese Medicine (TCM) belongs to the category of alternative medicine. Currently, Thai traditional medicine and Chinese acupuncture have been included in medical insurance. With Thailand’s approval of doctors to use Chinese medicine to treat diseases published (Notification No.1 of BE 2543), a series of activities such as the establishment of national TCM center, the certification of TCM doctors, and the set of TCM courses and training have promoted TCM development in Thailand. However, the application of Chinese herbal medicine is restricted by Thai medicine laws; the practical skills of acupuncture and moxibustion is insufficient; and the TCM education is not systematic and complete. Therefore, it is recommended to carry out extensive and continuous publicity in the future to promote policy and legislative support; to strengthen research and development of Chinese patent medicine on popular diseases in Thailand and promote localization; to establish a special practice training center to improve acupuncture clinical operation capacity; to add and refine the content of TCM regarding university education system as well as short-term training; and to encourage cooperation between China and Thailand in talent exchanges and scientific researches, promoting the development of TCM in Thailand.
ABSTRACT
Serbia is a parliamentary republic country in Southeast Europe. It implements a health security system with social insurance as the mainstay and social assistance as a supplement. Ischemic heart disease, stroke and Alzheimer’s disease are the major causes of death, and the mortality rates of cardiomyopathy and chronic kidney disease are increasing. Serbia has relevant legislation on traditional medicine. Acupuncture, as the main form of Traditional Chinese Medicine (TCM), has been introduced to Serbia in an early stage. Acupuncture was recognized as a legal medical method in 2005, and then the corresponding educational institutions of TCM were established soon. However, the limitation of acupuncture treatment application, difficulty in access to Chinese medicine, and undeveloped of TCM education system, all of them restrict the development of TCM in Serbia. It is recommended to improve the development and dissemination of Chinese medicine in Serbia, like to increase the promotion of acupuncture, pay attention to the Chinese medicine for preventive health care, and strengthen TCM education.
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Indonesia is an island country in Southeast Asia. In 2014, Indonesia established the National Health Insurance System (NHIS), and until 2019, the NHIS hadcovered 82% residents. The leading causes of death in Indonesia were stroke, ischemic heart disease, diabetes, tuberculosis and cirrhosis. In 1996, the Indonesian Ministry of Health allowed acupuncturists to enter Indonesian medical institutions to practice acupuncture. After that acupuncture was included in college education as a major course. However, there are still some problems, such as insufficient policy and legislation support of Traditional Chinese Medicine (TCM), imperfect education and talent training system of TCM, and low acceptance of TCM theories. Therefore, it is recommended that the local societies and organizations could actively promote the government’s legislation on TCM; local TCM schools could build a team of excellent teachers, improve teaching quality, and cultivate local TCM talents; strengthen the cooperation and exchanges of traditional medicine between the two countries to promote the spread and development of TCM in Indonesia.
ABSTRACT
Turkey is a presidential republic country located in the Eurasian continent, which has a universal health coverage since the health reform in 2003. The leading causes of death in this country are ischemic heart disease, stroke, and lung cancer. Besides, lower respiratory infections, chronic kidney disease, and hypertensive heart disease are the diseases which have a fastest growing rate. Chinese acupuncture was officially recognized by Turkey in 1991 with the promulgation of Acupuncture Treatment Legislation. At present, only trained practitioners and dentist could conduct acupuncture treatment, which was stated in Regulation of Tradition and Complementary Medicine Practice. The application of Turkish acupuncture and moxibustion is still applied in a simplified way that lack of TCM theory. Moreover, Chinese herbal medicine is still not officially recognized and still under control of the Ministry of Agriculture. Therefore, it is suggested to introduce TCM theory in the spread of acupuncture, to promote acupuncture research and clinical practice, to clarify the different standards between the two countries, and to cooperate in Chinese medicine researches, especially those related to the local high incidence and refractory disease so as to promote the development of TCM in Turkey and provide medical services for local residents.
ABSTRACT
South Africa is an ethnically and culturally diverse presidential republic country. The medical and health system consists of public and private medical care. AIDS, lower respiratory infections, neonatal diseases, and interpersonal violence and road injuries are the leading causes of adult death. South Africa has rich herbal resources, and a long history of traditional medicine, which is mainly black African traditional medicine. Until the establishment of diplomatic relations between China and South Africa in 1998, the development of TCM was significantly improved, and legislation of TCM was adopted by the government in 2000. Chinese herbal medicine has not yet formed industrial standardization, the TCM application and TCM education are insufficient. Therefore, it is suggested to accelerate the standardization of TCM, to strengthen the TCM education for professional TCM practitioners, and to form a large-scale, industrial and standardized development model. Only in these ways can TCM provide good medical services for residents in South African.
ABSTRACT
India is a parliamentary republic country located in South Asian. Its medical and healthcare insurance is paid by the state government and it has the world’s largest "free medical" service system. India has a long history of traditional medicine (TM) represented mainly by Ayurveda, Naturopathy, Yoga etc. As early as the 2nd century BC, Traditional Chinese Medicine (TCM) was introduced to India along with religious exchanges and trade activities. At present, acupuncture has achieved independent legal status in India and there are many acupuncture clinics and associations. However, non-acupuncture TCM treatments lack development in India, but the application of acupuncture lacks of systematic standards.
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This paper summarizes and analyzes the current conditions of Tanzania traditional medicine practitioners, organization structure, herbal medicine resources, and the exported pharmaceutic products and related companies. The result shows that Tanzania government gradually pays the attention to the development of its own traditional medicine industry. Due to the current TCM cooperation dilemma with Tanzania, coping strategies should be adopted to provide certain references for the next stage of China-Tanzania TCM cooperation, such as adjusting the professional fields of dispatched experts, adjusting cooperative fields, including the export and investigation of TCM companies to Tanzania.
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The paper analyzed the scale, educational background, degree, and financial source of the European students in Chinese TCM colleges and universities by using excel 2013. The results showed that there were 19 TCM colleges and universities recruiting European students, and the number of campus students, enrollment students, graduation students were 409, 257 and 280 in 2017 respectively. The campus students in 2017 was highest since five years ago, but was less than the Afro-Asia states. Training was main form of studying abroad. Most campus students were at their own expenses, or received the help from Chinese government. The education for European students in Chinese TCM colleges and universities has made some achievement, but there were still some questions: the European students was not too much, the education's attraction was not strong, and the financial help from international organization and foreign government was scarce.
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The paper analysed the scale,character,cooperation countries,funds and achievements of the traditional Chinese medicine (TCM) international projects between China Academy of Chinese Medical Sciences (CACMS) and Europe from 2007-2017.The results showed that there were 44 projects between CACMS and Europe;the number of Chinese medicine,clinical and basic research projects were 21,9 and 6 respectively;the number of projects between CACMS and Austria,and between CACMS and Gemany were 20 and 8 respectively;the funds from Ministry of Science and Technology and CACMS accounted for relatively high proportions.Trough these projects between CACMS and Europe,the TCM centers were established,the key technologies were introduced,and the professionals were trained.But there were still some questions such as the regional maldistribution of cooperation countries,few acupuncture research,and little project funds.
ABSTRACT
Vigorously development of the health service industry has received great attention,but the health service industry faces many difficulties.By analyzing the current predicament,this paper put forward the KY3H health care service model and systematically analyzed its six innovations:from "disease as the center" to "health as the center",from "homogenized group health service" to "Personalized and Humanized Health Service",from "Extensive Health Service"to "Precise Intervention of Individual Health Status",from "Single Health Service" to "Trinity Service of Health,Culture,Health Management and Health Insurance",from the "seeking medical" service model to "seeking one's own"service model,as well as from the "fixed (fixed-time,fixed-point,fixed-mode) service" to "anytime,anywhere full-time service".This model has achieved initial success in practice.It is an important way to solve the dilemma.