A new approach to the internationalization of traditional Chinese Medicine

If the diet supplement health and Education Act (DSHEA) of the United States is the result of the competition between the government and the business, then the natural health product regulation (nhpr) of Canada can be regarded as the product of the consultation between the government and the business The introduction of nhpr coincides with the 10th anniversary of DSHEA (2004) After ten years of observation, the Canadian government and Congress did not copy the United States After extensive consultation with stakeholders, Health Canada has developed a new approach to regulate the newly named "natural health products" category The highlight of the bill is that it can accommodate all kinds of natural medicines and health products And give them a certain "space" to play their own characteristics Thus, it opens the door to the market of medicine and health care products in Canada for traditional medicine and non western orthodox natural products in the world At the same time, it opens up a new way for the internationalization of traditional Chinese medicine The very different starting point of approval is that "natural health products" in Canada basically include all "dietary supplements" products in the United States, and then add other categories such as "traditional medicine" and "homeopath medicine" Although the products covered by "dietary supplements" and "natural health products" look very similar, the starting points of legislation and regulation of the two types of products are quite different The former is based on food to reduce the regulatory threshold to promote the development of the industry The latter regards "natural health products" as a sub category of drugs And stand in the position of drug monitoring, from the perspective of national health insurance to plan regulatory programs The goal is to provide the largest quantity of safe and effective natural medicine, traditional medicine, homeopathic medicine and health care products to the public and the medical system at a lower cost Because "dietary supplements" are nutritional products, FDA does not allow them to make functional and therapeutic claims (with the exception of several designated claims) Although the American "dietary supplement" market has a low threshold and is easy to enter, most traditional Chinese medicines belong to therapeutic and conditioning products, and there is no channel set in this mechanism for the product to fully disclose its function and efficacy, so that consumers cannot obtain sufficient information to make good use of it Therefore, traditional Chinese medicine in these markets is in a "difficult to say" situation As a result, its ability to exploit the market has been greatly weakened Therefore, traditional Chinese medicine is not suitable to enter the U.S market as a "dietary supplement" Premise: the product must be safe in Canada Since "natural health products" belong to a subcategory of drugs, it is allowed to make treatment and function claims in a wide range after approval The condition is that these claims must be supported by sufficient scientific and clinical data Another possibility is that these claims must fully conform to the theory of "traditional medicine" and be expressed in terms of it If the product adopts the latter, it must be clearly stated that it is a claim of "traditional medicine" to distinguish it from the claim based on modern science and clinical These procedures of nhpr coincide with the situation of traditional Chinese medicine Therefore, the approval process of "natural health products" will naturally become an ideal channel for "internationalization of traditional Chinese medicine" In order to ensure that people are properly protected, the premise of nhpr registration is that the product must be safe In other words: the drug must be "OTC"; functional food must also be absolutely safe Health Canada, Health Canada, will not confirm the efficacy and function of the product until it has full confidence in the safety of the product Finally, GMP production certification was made Only products that have passed the whole approval process can be put on the market This is in sharp contrast to DSHEA's basically limited "notes" without formal approval Nhpr, a more tolerant treatment of "traditional drugs", has been criticized by the western orthodox medical community But for the "traditional medicine" with high safety, it is a convenient way This is even more a moral policy for ethnic minorities in Canada With nhpr, they can use drugs and health care products that they are familiar with and trust legally and confidently The government can also save a lot of public health expenditure The state and the people benefit at the same time Chinese patent medicine failed to go out of Chinatown because nhpr adopted a more open attitude to regulate natural "traditional drugs" Traditional drugs such as Chinese patent medicine have the opportunity to enter the western market represented by Canada through registration In principle, once a product has obtained the product approval and production approval, it will be eligible to enter the Canadian market, but whether it can truly enter the "mainstream market" is another matter If the product only obtains two approvals through traditional theories and terms, the customers of the product may only be limited to minority communities Therefore, it is not necessary to break through the barriers of culture, science and technology, language and market on the road of "internationalization of traditional Chinese medicine" only by obtaining the approval Therefore, before entering the Canadian market, the Chinese patent medicine must deploy its full strength in medicine culture, clinical practice, production, science and technology, language and market strategy With these conditions, it is possible for the medical profession, the government's medical service system and ordinary people to be happy to use the product after mastering the information of the product and generating confidence After nhpr was introduced in 2004, only after a period of "digestion" can the industry fully grasp and understand the meaning, characteristics and business opportunities of regulatory content Within a few years, the number of applications has reached tens of thousands In recent years, a number of Chinese patent medicine products have obtained the import and sales qualification of "traditional medicine" However, due to the lack of clinical and scientific data, most of them are difficult to surpass the market outside Chinatown At present, only a few Chinese patent medicines have been approved by the health department of Canada according to clinical and scientific data Therefore, there is still a long way to go for the internationalization of traditional Chinese medicine through Canada From the standpoint of nationality, culture and humanity, it is incumbent on the Chinese medicine community to promote the "internationalization of traditional Chinese medicine" It is hoped that this paper can arouse the industry's wide interest in "internationalization of traditional Chinese medicine", and work together to improve the clinical data and scientific content of products, so that more traditional Chinese medicine can finally enter the western international market and even the global market through official registration.