Standardization is the golden key to traditional Chinese medicine "Westward"

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Business Club November 26th

According to reports, due to the gradual standardization and standardization of acupuncture and massage, it has gradually been accepted by the world. In contrast, the standardization of traditional Chinese medicine is even more arduous. Not long ago, China's proprietary Chinese medicine compound Danshen Dripping Pill was approved by the US Food and Drug Administration (FDA) to start the FDA three-stage large-sample clinical trial early next year, and is expected to become the first proprietary Chinese medicine to enter the mainstream market in Europe and America.

Chinese medicine is an indispensable part of Chinese civilization. However, although Chinese medicine has been introduced to the world for many years, it has always been in a "supportive role" position and it is difficult to enter mainstream Western society. There is still a lack of studies on the formulation, safety, and effectiveness of traditional Chinese medicines.

It has been optimistically predicted that the Chinese medicine industry will be one of the industries with the most development space in the 21st century. The world's herbal market sales are currently increasing at a rate of 10% to 20% per year. This is undoubtedly an excellent opportunity for China, which has unique Chinese medicine resources.

However, at present, there is a problem of inconsistent standards and unstable quality in the Chinese medicine industry. Li Lianda, an expert in pharmacology of the famous Chinese medicine and an academician of the Chinese Academy of Engineering, once pointed out that the chaos of quality standards is the main “bottleneck” of traditional Chinese medicines in the world, and the “standardization” of Chinese medicines needs to be strengthened. Quality standardization is the basic guarantee for safe, effective, and stable quality of Chinese medicine, and it is also an essential “hardware” for Chinese medicine to go to the world.

As the birthplace of Chinese medicine, China has more than 10,000 kinds of Chinese medicine resources and more than 4000 kinds of Chinese medicine preparations. However, in the current international medicine market with more than US$16 billion, China has less than 1% of the market share, and about 70% of them come from Chinese herbal medicines. The high value-added Chinese patent medicine exports are minimal. In Li Lianda's words, the factors influencing Chinese medicine's going global are summed up in three aspects:

The first is the cultural background. The cultural background of the East and the West is very different and there are certain difficulties in the communication between Chinese medicine and Chinese medicine. Second, there is not enough "modern Chinese" in traditional Chinese medicine. Most of the Chinese medicine literature is ancient Chinese. Some of them are languages ​​3,000 years ago. Not to mention foreigners, ordinary Chinese people are also struggling to read and comprehend, and the "old language" should be converted to "modern Chinese" as soon as possible. Third, the quality standards of Chinese medicine are confusing. The quality standards of Chinese medicine companies can be described as "respective of their own governance," affecting Chinese medicine to the world.

As part of the world's medicine, Chinese medicine has been widely spread throughout the world in thousands of years of development. Compared with western medicine, the unique advantages enjoyed by traditional Chinese medicine are increasingly recognized by the world. The potential of SARS and AIDS in the treatment of Chinese medicine is of global concern. International organizations such as the World Health Organization and UNESCO have attached great importance to it. Support the development of Chinese medicine. This will greatly benefit the internationalization of traditional Chinese medicine.

Chinese medicine cannot be left behind and should go abroad. However, the process of Chinese medicines applying for Western pharmaceutical standards has been quite lengthy. For instance, after the compound Danshen Dripping Pills received a clinical trial approval document from the US FDA in 1997, only phase II clinical trials were initiated until 2007. The author believes that whether it can develop a new type of traditional Chinese medicine that is welcomed by the international community is a direct influencing factor for entering the European and American markets. Chinese medicine should be injected into the strong competitiveness of modern science and technology, and the "gold content" of Chinese medicine should be enhanced with verifiable effectiveness, and the old Chinese medicine should be equipped with the golden key of "western progress."

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