Internationalization of Traditional Chinese Medicine

Lin et al. Chin Med (2018) 13:9 https://doi.org/10.1186/s13020-018-0167-z Chinese Medicine

REVIEW Open Access Internationalization of traditional Chinese medicine: current international market, internationalization challenges and prospective suggestions Annie Xianghong Lin1, Ging Chan2, Yuanjia Hu2, Defang Ouyang2, Carolina Oi Lam Ung2, Luwen Shi1 and Hao Hu1,2*

Abstract Through reviewing the current international market for traditional Chinese medicine (TCM), this paper identifed the internationalization challenges for TCM, including unclear therapeutic material basis and mechanism, difculty of quality control, low preparation level, registration/policy barriers, and shortage of intellectual property. To deal with these challenges, suggestions were given including: (1) product innovation of TCM (study the TCM by using the methods and means of western medicine; innovate the basic theory of TCM; develop TCM health product); (2) standard innovation of TCM; (3) building big data platform of Chinese medicine (big data platform of TCM preparation; big data platform on the quality of TCM). Keywords: TCM, Internationalization, International market, Quality control, Standardization

Background the “going abroad” of TCM, to promote the sustainable Traditional Chinese medicine has an extensive history development of TCM international trade and to foster and, for 5000 years, has been the fruit of the Chinese the TCM market share across the countries; (2) the legal people’s intelligence in the struggles against diseases. status of TCM in overseas countries has to be appropri- With the advancement in medicine and technology, and ately established to ensure reasonable market entry and the quest to better understand the science of natural to enable sustainable development of TCM under the medicine, the interests in and acceptance of traditional protection of the local laws and regulations [2]. Chinese medicines (TCM) continues to grow. Featured After more than 2 decades of commitment to the with the long history of use in treating certain challeng- internationalization of TCM nationwide, the progress ing diseases resulting in curative efects, comparatively appears to be stagnated. In order to formulate strategies lower costs and reportedly less side efects, the role of to achieve a break through, the obstacles inhibiting the TCM in health is widely recognized around the globe [1]. internationalization of TCM need to be reviewed system- In 1996, China newly introduced the concept of atically. However, limited studies on the challenges facing “internationalization of TCM” which comprised of two the internationalization of TCM, this paper aims to study major aspects: (1) it is important to expand the volume the current international market for TCM, to analyze of import and export of TCM in order to push forward internationalization challenges, and to propose solutions that can help facilitate the internationalization of TCM in the future. *Correspondence: [email protected] 2 State Key Laboratory of Quality Research in TCM, Institute of Chinese Medical Sciences, University of Macau, Room 2057, Building N22, Avenida da Universidade, Taipa, Macao Full list of author information is available at the end of the article

© The Author(s) 2018. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/ publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Lin et al. Chin Med (2018) 13:9 Page 2 of 6

Analysis of the current international market became the largest market of TCM exported from China for TCM [5]. Although TCM has a large, promising world mar- Internationalization of TCM has seen a decline in the ket, it also has many obstacles. TCM’s entry into the volume and value of export. According to the China Cus- American market requires the approval of the Food and toms statistics, the import and export value of TCM in Drug Administration (FDA), which implies large capi- 2016 experienced a negative growth for the frst time in tal (over 100 million USD) and lengthy process (lasting nearly 10 years despite a slight increment in the import at least 8 years). However, the more stinging problem in and export value of Chinese pharmaceutical products the entry process is that the risks of American fnanc- compared to 2015. Te total value of TCM import and ing support for TCM enterprises implementing inter- export in 2016 was 4.6 billion USD, accounting for 4.45% nationalization strategy are still neither clear nor strong of the total value of the import and export of Chinese enough [6]. With the implementation of “Regulations for pharmaceutical products. While the export value of Botanical Drug Approval” and “Guidance for Industry: TCM in 2016 dropped by 9.13% compared to 2015 from Botanical Drug Development”, the United States began 3.77 to 3.426 billion USD, the import value achieved a big to consider botanical drug compounds as a therapeutic reversal, increasing 14.50% from $1.025 billion in 2015 to drugs. Take “Xuezhikang (XZK)” for an example, with 1.174 billion USD in 2016. the special fund support for innovation and prepara- TCM encompasses a wide range of items: traditional tion of major new drugs designated in the 12th 5-year of Chinese medicinal materials, decoction pieces, Chi- China, it entered the FDA clinical trial. Tis is the frst nese patented medicines, herbal extracts, and health time for domestic clinical organizations to participate in care products. Te export volume and values of most of registration and clinical study of lipid regulating TCM these items have declined over the years. For instance, in FDA. For “Xuezhikang (XZK)” to enter clinical phase the export value of Chinese medicinal materials and successfully, a good clinical trial protocol should be well decoction pieces in 2016 was 1.025 billion USD, a 3.13% prepared and the proper indications with supplementary decrease in growth rate year-on-year. For the health care functions to be tested in the clinical trials should be well products, the export value in 2016 was 249 million USD selected [7]. which was a 13.22% reduction from the same period of Te drop of the two major markets in Hong Kong and the previous year. Te export value of the Chinese patent Japan is another major reason for the decline in the over- medicines was 225 million USD in 2016 which is equiva- all TCM export value and export volume. Japan was once lent to a decrease by 13.94% as compared with the pre- the largest importer of Chinese medicinal materials and vious year with the export volume declined greatly. Te mainly involved Chinese medicinal materials and decoc- most signifcant impact on the declined volume and value tion pieces [8]. But after 1990, Japan began to vigorously of export came from the Chinese herbal extracts. In the develop the herbal medicine base and establish the herbal past, these extracts were on high demand as the market plantations in order to become self-sufcient of medici- for new products of essential oil bloomed both nationally nal herbs and to reduce import from China, which led and overseas. Te Chinese herbal extracts were the larg- to Japan’s falling import of volume and value of Chinese est and fasting growing item among all Chinese pharma- medicinal materials. In 2016, the market began to pick ceutical products in 2015, accounted for the largest share up, embodied in the growth of export volume and value. of the total export of CM. While the export value of Chi- Today, Japan has become the second largest market for nese herbal extracts accounted for 56.2% in 2016, it failed TCM exports next to the United States, with an export to maintain a growing trend. Te export value was only value of 505 million USD in 2016, a 6.62% increase over 1.972 billion USD in 2016 which was a decrease of 10.93% the past year. Tere are more than 200 Japanese Kampo compared to that of last year, and the export volume also medicine manufacturers in Japan. Tese domestic enter- decreased by 14.3% [3, 4]. Te signifcant downfall in the prises possess advanced equipment and technology to export value of herbal extracts greatly contributed to the process Chinese medicinal materials and to manufacture overall negative growth of TCM export. quality-stable TCM under strict standards. Te locally TCM were exported to 185 countries and regions and manufactured TCM has occupied a considerable share of its main markets still remained in Asia with the dominant the markets of Chinese patent medicines and health care target markets located in Hong Kong, Japan, Malaysia, products. In South Korea, the drop in the sales of TCM South Korea and Indonesia. Next to Asia was the United manufactured in China was multifactorial: the issues with States. In 2016, China exported 526 million USD worth the packaging design and promotion strategy of TCM of TCM to the United States, accounting for 15.34% of discouraging the use and masking the true value of TCM TCM exports for China. It is anticipated that the United in health; and concerns over the content of heavy metals States would soon overtake Hong Kong and Japan and and pesticide residues exceeding the national standards, Lin et al. Chin Med (2018) 13:9 Page 3 of 6

which are a lot more stringent compared to standards by the study model of “single component and single tar- alike in many developed countries [9]. In addition, many get” in modern medicine. Te uncertainties in the efec- developed countries have set up high green trade barri- tive substance basis and the mechanism of TCM further ers and technical trade barriers for TCM entering their make it difcult to formulate a scientifc and efective countries, hindering the process of internationalization system for evaluating the efcacy and safety of TCM. of TCM. International communities always fnd it hard to recog- Another factor discouraging the internationalization nize and adopt the quality standards and the standards of TCM is the high policy thresholds. In certain coun- of production management of TCM. As a result, Chinese tries such as Russia, Vietnam and Australia, TCM is sold patent medicines lose their competitiveness the interna- as a pharmaceutical drug. In many other countries and tional market [11]. regions, however, TCM are approved for sales as health Te quality control of TCM is directly related to the care product, active pharmaceutical ingredient (API), safety and efectiveness of TCM and is critical to the or dietary supplement. On 1st May 2011, the European internationalization of TCM. China has set up a qual- Union’s 2004/24/EC EU Directive on traditional herbal ity inspection technology system focusing on chemical medicine (namely the EU botanical drug approval and marker detection. Tis method has gradually developed continuity clause) came into force. Tis directive of the into quality analysis mode of quantitative analysis, chro- European Union provides a simplifed registration proce- matographic fngerprint, and discriminant analysis from dure for traditional herbal medicines, and gives a 7-year the initial sensory experience. However, the research pat- transition period of the traditional herbal medicine sold tern of the quality control of TCM is still relying on the in the EU market before 2004. However, after 7 years, analysis method research. Tis requires careful determi- all unregistered traditional herbal medicines will be nation of focusing on the quality inspection of Chinese removed from the EU market [10]. At present, Diaoxinx- traditional medicine and ignoring the quality control uekang capsule, which is developed and manufactured by during the production process; paying attention to the Chengdu Diao Pharmaceutical Group Company, is the chemical markers detection and ignoring the biomarkers; only one China-manufactured traditional herbal medi- and emphasizing the drug quality analysis and evaluation cine marketed and sold in the EU market. It is approved and ignoring the study on the medicines regulation sys- as the secondary-types of TCM new drugs and carries tem. Te scientifc and reliable quality assurance system Chinese independent intellectual property rights. Tis complying with the characteristics of TCM are yet to be exceptional product helped demonstrate how a high fully constructed [12]. Meanwhile, assurance of TCM policy threshold is translated into great obstacles to safety is also a difcult task added to the quality con- the entry of TCM into the international market, greatly trol of TCM. Many countries have added test items of reducing the export volume of TCM in the EU market microbes, preservatives, pesticide residues, heavy metals especially the British market. and afatoxin for traditional medicines and herbal health foods, and formulated their national standards present- Internationalization challenges for TCM ing signifcant cross-country variations. Although China Te therapeutic material basis and mechanism of TCM has strengthened the quality control in microorganisms, are key to the quality, efectiveness and safety of TCM, pesticide residues, heavy metals and arsenic salts, there and are the fundamental prerequisite for the internation- is still a large gap between Chinese and international alization of TCM. Te efective substance basis of TCM standards. is the general name of chemical components that bring Te low level of dosage form is one of the important about the clinical efcacy of the medicine. Due to the factors that restrict TCM internationalization. Te mod- diversity and complexity of compound structures, a TCM ernization level of the TCM formulation is relatively is a natural “combinatorial chemical sample library.” backward. Tablets, capsules and granules accounted Tere are more than 200,000 known compounds in for more than half of current TCM dosage form. Te TCM, but currently only a few compounds such as arte- advanced dosage form for TCM such as sustained- misinin and arsenious acid have been studied thoroughly release, controlled-release and targeted preparations and clearly for their pharmacological action and biologi- are still in the research stage. Te majority of small and cal mechanism. Te targets and biological mechanisms of medium-sized TCM enterprises still use the traditional most compounds still remain unknown. excipients, which makes it difcult for the TCM formu- On the other hand, each TCM consisting of multiple lation to meet the international standard requirements. compounds is a complex chemical system. Its character- Te basic research on TCM formulation is backward, istics of synergistic reaction of multi-components, multi- especially the researches on pharmacokinetics, stability, channels and multi-targets are difcult to be elucidated dose–response relationships, etc. are relatively scarce. Lin et al. Chin Med (2018) 13:9 Page 4 of 6

Te internationalization of TCM is also faced with a research of new formulations of Chinese herbal prepara- number of registration/policy barriers. Along with the tion; attempts should be made to achieve breakthrough gradual expansion of the international market of natural on traditional dosage forms such as bolus, powder, plas- medicines, some developed countries have implemented ter, and pellet, and develop new formulations with high trade protectionism in order to protect the interests of bioavailability, convenient administration and high level the domestic pharmaceutical companies and related of quality control” [16]. In addition to the innovative medical services, set up a multitude of technical bar- research and development of monomeric drugs and dos- riers to trade and continue to strengthen the manage- age forms, the methods and means of western medicines ment measures of the import Chinese patent medicines, can also be adopted in the research of TCM prescription which seriously hampered the process of the interna- as deemed appropriate. Prescription of TCM is not just a tionalization of TCM. Tese technical barriers to trade combination of TCM ingredients. Tere are new ingredi- are various, such as technical standard barriers, techni- ents generated in the formation of prescriptions, which cal regulation barriers, patent technology barriers, green warrants thorough analysis of the active components and barriers, etc., which makes Chinese products fail to enter the extractions. Tis is considered conducive to the rapid or forced to withdraw from the target market due to development of TCM research and development [15]. shortcomings in technology, environmental protection, and other areas mandated by the policy and regulations. Innovate the basic theory of TCM Te intellectual property of TCM is also the weak link TCM has its own connotations and it is not simply equiv- of the internationalization of TCM. Tere are multiple alent to botanical drug. If the TCM pursues westerniza- issues related to the patents of TCM: low international tion and abandons the theory of TCM, the research road patent application, low efective patents, numerous inva- of the TCM will be narrower and narrower [17]. Diferent lid patents, low patent quality and fast growth of appli- from the western medicine which starts from the molec- cation volume not transformed into a rapid growth of ular biology, TCM is researched and developed based on market share and so on [13]. At the same time, there are systematic biology. After a long time of use, the toxicity also many problems in the technology transfer of TCM, and efcacy of TCM becomes clearer [18]. Rather than including lacking of original innovation, lacking of basic exploring from the very beginning and exploring phar- research, serious shortage of R&D investment, disloca- macological action from pharmacological experiments, tion of R&D subjects, imperfect market transformation the most important thing in TCM research and develop- and industrialization mechanism, and weak service links. ment is to explore and utilize ancient medicine literatures and thousands of years of clinical experience. Suggestions for further internationalization of TCM Te improvement of clinical research of TCM can also Te cross integration of multidisciplinary and innova- drive the innovation and development of TCM. Tis tive drug research and development have brought new provides a ground where the concepts and methods of opportunities for the development of TCM [14]. evidence-based medicine, the principles of international clinical research, and the characteristics of TCM clinical Product innovation of TCM research can all be combined. In recent years, sufcient Study TCM by using the methods and means of western experiences in the exploration of the clinical research of medicine TCM has been accumulated for the design of measures With the continuous development and progress of mod- that promote the improvement of the overall levels lead- ern science and technology, the technology of quality ing to many landmark achievements. For example, apri- identifcation, extraction and separation, analysis and cot Shi Gan Tang with Yinqiao powder for the treatment detection of TCM is becoming more and more mature, of H1N1, etc. [19]. and its action of mechanism and active components In order to demonstrate the scientifc, technological are becoming increasingly clear. In addition, the mod- and economical values of the TCM industry for its sus- ern chemistry, biology, physics, information science tainable development, academician Zhang introduced and other disciplines have continuously permeated the the concept of the secondary development of TCM. Tis feld of research and development of TCM, which pro- concept refers to the re-development of the TCM prod- vides a new model for the research and development of ucts which have good clinical efcacy and signifcant TCM [15]. Academician Zhang once suggested that “the market share in order to promote the redesign of the development of new varieties of TCM should focus on TCM product, accelerate the cultivation of famous Chi- the research and development of TCM with high tech- nese medicine varieties and develop China’s own “block- nology content such as component medicine and drug buster” drug [20]. With the help of modern science and monomers, etc.; special attention should be paid to the technology, the development of a safe, efective, stable Lin et al. Chin Med (2018) 13:9 Page 5 of 6

and controllable compound Chinese medicine is promis- Building big data platform of TCM ing [21]. Big data platform of TCM preparation A systematic and transparent preparation of large data Development of TCM health product information platform of TCM preparation is key to com- Globally, one of the sunrise industries pivot towards prehensive mining of the vast amounts of information health care products, which are referred to as “health- on TCM and its preparation feld, professional process- care food”, “functional food” and “food supplement” in ing of data—drawing of scientifc knowledge map, tracing diferent countries. With the 1000 years of usage history, patent data, digging and analyzing of clinical trial data the TCM healthcare products have huge international and marketed drug data, drawing the navigational chart market potential and room for expansion [22]. Health- of TCM and its preparation in the era of big data. Te care products of TCM provide a great potential route establishment of the platform will efectively integrate for TCM to enter the international market. Chen Shilin all aspects of TCM research and development, serve the pointed out that “TCM has the homology tradition of needs of multiple demand groups including enterprises, medicine and food”. Among them, many Chinese herbal government regulators, academic research institutions, medicine and decoction pieces can enter the market as and so on, and greatly shorten the development time of health products. However, the TCM are facing many new varieties of Chinese medicine and its preparation. challenges including export volume decreasing, uneven distribution of export areas, and less proportion of devel- Big data platform on the quality of TCM oped regions such as in the US and EU as well as lacking Te quality data platform of TCM includes the qual- of brands winning the trust of the customers” [23]. Te ity standards of Chinese medicinal materials, decoction industry of TCM health products should strive to estab- pieces, and Chinese patent medicine, so as to enhance lish a sound quality management system, seek protection the research on the technical standards and specifca- of the processing technology, establish quality identifca- tions of varieties, quality, planting, collecting, processing, tion and intellectual property rights, and select appropri- preparing of decoction pieces and extraction of TCM. ate promotion and sales strategy [24]. For example, the DNA barcode species identifcation system that was jointly established by the National Key Lab- Standard innovation of TCM oratory of TCM quality in Macao University and Beijing In order to enter the international market, the key step of Union Medical College won the second place of the 2016 promoting TCM is to optimize our own standard to make National Science and Technology Progress Award. Tis it acceptable to the international market [25]. Te impor- barcode species identifcation system has established a tant method is to include the standard of TCM in the “genetic identity card” for TCM. Te achievement also national pharmacopoeias such as the US Pharmacopoeia established the world’s largest TCM DNA barcode identi- or the European Pharmacopoeia. More than 140 coun- fcation database, which contains more than 1.70 million tries in the world have adopted the US pharmacopoeia, DNA sequences, and may achieve rapid identifcation while the European Pharmacopoeia standard is widely to almost all herbal species included in CP, USP, JP, EP, used among all the European Union country members. South Korea Pharmacopoeia and India Pharmacopoeia, Being included in these two Pharmacopoeia indicates etc., and promote TCM identifcation study to enter into a global acceptance of the TCM standards which will the standardized gene identifcation era. greatly beneft the internationalization of these products. In recent years, 27 standards of “9 varieties” such as sal- Concluding remarks via miltiorrhiza, pseudo-ginseng and ganoderma have To promote the internationalization of TCM, the govern- been included in the US Pharmacopoeia, and a number ment, academic institutions and industry must cooperate of standards have entered the US Pharmacopoeia audit closely, and establish an international platform for the procedure [19]. More than 10 TCM standards including development and communication of TCM rather than uncaria and platycodon entered the European pharmaco- just the domestic eforts limited in China. Te estab- poeia or forum. Tese achievements have proved to the lishment of the international cooperation platform is world that TCM can also be evaluated according to inter- not only conducive to the internationalization of TCM national standards, which brings new prospects for the but also provides opportunities for other countries and entry of TCM into the international market. regions to develop traditional medicines, so as to better Lin et al. Chin Med (2018) 13:9 Page 6 of 6

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