The business club reported on January 17 that the medical cooperation between the two sides of the strait ushered in a milestone on December 21 last year. The leaders of the Cross-Straits Relations Association and the Taiwan Straits Exchange Foundation jointly signed the "Straits Medical and Health Cooperation Agreement." The agreement includes substantive contents such as cooperation in the prevention and control of infectious diseases, safety management of pharmaceuticals and Chinese herbal medicines, clinical trials and cooperation in pharmaceutical R&D. As a result, the pharmaceutical markets on both sides of the Taiwan Strait can achieve a certain degree of connection.

As far as the Chinese medicine industry is concerned, the mainland's infusion of Taiwanese medicine mainly consists of Chinese herbal medicines, decoction pieces, and extracts. The proportion of health care products and proprietary Chinese medicines is relatively small.

Management: Chinese Medicine Committee plays an important role in promoting

In 2009, the total amount of medical expenses paid by the Taiwan Health Insurance Bureau was 132.3 billion New Taiwan dollars, of which, the total amount paid for traditional Chinese medicine concentrates was NT$6.31 billion, accounting for 4.8% of the total paid medical insurance fees. At present, over 800 species of Chinese medicines that can be reimbursed are approved by the Taiwan Health Insurance Bureau. The annual intake of Taiwan’s Chinese Medicine Hospital is about 36 million.

The administrative administration of Taiwanese Traditional Chinese Medicine is affiliated with the "Department of Health of the Executive Yuan" of Taiwan. It mainly deals with its subordinate "Chinese Medicine Council", "Pharmacy Affairs Office", and "Medicine and Food Inspection Bureau". Among them, the “Traditional Chinese Medicine Committee” has played an important role in promoting the development of traditional Chinese medicine in Taiwan Island.

The “Traditional Chinese Medicine Committee” is mainly responsible for handling inspections, registrations, alterations, and extension of licenses for Chinese medicines; revising regulations and laws related to Chinese medicines; promoting the implementation of a GMP system for Chinese medicine factories; establishing a management system for Chinese medicinal materials; and revising clinical trial methods for traditional Chinese medicines. The committee is also responsible for supervising the quality management of Chinese herbal medicines and implementing the source management of Chinese herbal medicines. In 2009, the committee evaluated and determined the preparation methods of 57 varieties of Chinese herbal medicines, and compiled the "Common Chinese Medicine Preparation Series" for the reference of each GMP Chinese medicine factory on the island.

In addition, Taiwan has also standardized on the quality standards of Chinese medicines, and made demands on pesticide residues, heavy metals, and aflatoxin limits. While implementing the quality control of Chinese medicinal materials, Taiwan is also actively strengthening the management of traditional Chinese medicine preparations.

Status Quo of the Industry: Medicinal Materials Depend on Mainland Imports, High Level of Quality Control of Chinese Patent Medicines

Taiwan's Chinese herbal medicines are mainly imported and have a high degree of dependence on Chinese herbal medicines. Although there are more than 2,000 kinds of plants with medicinal value in Taiwan, the resources of traditional Chinese medicines are still limited. The pharmaceutical factories mainly import Chinese herbal medicines from outside Taiwan and then process them into preparations for sale.

The annual import of Chinese herbal medicines in Taiwan is generally around NT$2.4 billion (excluding extracts and imports in the name of food), mainly ginseng products, accounting for 28.5% of the total imports of medicinal herbs. 60% to 70% of imported medicinal materials come from the mainland, and mainland China is the sole source of imports for many medicinal herbs in Taiwan. The most used herbs in Taiwan are ginseng, angelica, Chinese wolfberry, yellow peony, and fritillary. Taiwan's largest use of medicinal herbs pieces were Angelica, Rehmannia, Licorice and Chuanxiong.

The total value of terminal products from mainland medicines has reached NT$ 68 billion. At present, 6.2% of the Chinese herbal medicines from the mainland are mainly used for the production of Chinese medicine preparations, the other 30% are mainly used for food processing (spices, seasonings and health food raw materials), and 33.8% are used for traditional Chinese medicines (Chinese medicine prescriptions, herbal supplements). The last 30% is used for animal feed additives, cosmetic raw materials and raw materials for environmental hygiene products.

Chinese herbal medicine has become the main raw material for Taiwan's health foods, and its function is mainly lipid-lowering. At present, there are more than 190 kinds of products that have passed health food certification in Taiwan, of which more than 70 kinds (close to 40%) use Chinese herbal medicine as raw material, and the main components are tea, ginseng and fungi. Chinese herbal medicine health food has the highest proportion of hypolipidemic and hepatoprotective, followed by immune regulation and anti-fatigue. These 4 functional products account for more than 80% of all herbal health foods. Overall, in the 13 efficacy certifications passed by the Taiwan Department of Health, in addition to dental care, assisting in the adjustment of allergies and regulating blood pressure, Chinese herbal products are found in 10 other functions.

The overall growth of the Chinese medicine industry in Taiwan is slow and the domestic sales are dominated, but it has reached a world standard in the quality control and production technology of Chinese medicine preparations.

As of the end of 2009, the total number of GMP pharmaceutical factories in Taiwan reached 118, of which the output value of traditional Chinese medicine preparations accounted for only 1/10 of the output value of Taiwan's pharmaceutical industry. In the past 7 years, the annual output value of Taiwanese herbal preparations has basically remained around NT$5 billion. Due to the limited market consumption on the island, the growth of the Chinese medicine industry in Taiwan is also relatively slow, with an annual growth rate of only 2%.

Taiwanese medicine factories are mostly small and medium-sized enterprises, and there are three major categories of Taiwanese traditional Chinese medicine preparation industries, namely, “concentrate formulations” derived from Japan, accounting for 71.5% of the total output value of traditional Chinese medicines, and “traditional dosage forms” of granules, which account for traditional Chinese medicines. 28.2% of the total production value; "Western medicine type", accounting for about 0.3% of the total output value of Chinese medicine. The manufacturers with more than RMB 100 million in capital include Shengchang, Shuntian, Keda and Hong Kong Panda. At present, the Chinese medicine preparation plant in Taiwan has fully implemented the GMP system. In addition, some concentrated preparation plants have already begun exporting to Japan after 1970. Therefore, they have reached the world standard in quality control and production technology.

The sales of most Chinese medicine preparation companies in Taiwan are dominated by the island market. The sales in the island market account for 4/5 of the total production value of traditional Chinese medicine preparations. The export market of Taiwanese traditional Chinese medicine preparation products is dominated by Asia and exported in 2009. The markets are mainly Singapore, United States, Japan, Malaysia and Hong Kong.

Therefore, the potential of Taiwan's proprietary Chinese medicine market remains to be developed. At present, the export volume of Taichung's proprietary Chinese medicines on the mainland is not large. The main reason is that Chinese patent medicines still belong to unopened projects. Chinese proprietary Chinese medicine products cannot enter Taiwan in accordance with normal channels. The Chinese patent medicine products are mainly re-exported to Taiwan via Hong Kong. The Taiwan authorities accept that Hong Kong companies submit applications for drug registration to the Taiwan authorities. However, the Chinese patent medicine market in Taiwan still has a certain level of capacity. Its level is no less than some countries in Southeast Asia. There are 1985 Chinese medicine medical institutions in Taiwan, including 109 Chinese medicine hospitals, 1876 Chinese medicine clinics, and approximately 13,000 Chinese medicine houses.

Advantages: There is room for cooperation from R&D to marketing

Despite the slow market growth, Taiwan's traditional Chinese medicine industry has accumulated certain advantages: its quality control is strictly regulated by the international market; it has been recognized by the international market; traditional Chinese medicine concentrate preparations have been used for 46 years and have accumulated valuable experience; The marketing network is basically shaped. Many orders come from Europe, America, Japan, and Southeast Asian countries; there are a large number of new Chinese medicines developed, and the pace of progress is fast.

Rich in basic research, it is the backing of Taiwanese herbal medicine research and development. As early as the 1960s, Taiwan had begun to research and identify the herbal sources and chemical components of Chinese herbal medicines and Taiwan folk herbs. It has accumulated considerable foundation so far. The North Doctor Institute has been researching for decades and has accumulated more than 600 medicinal herbs, over 100 kinds of medicines, and established a database of Chinese herbal medicines. Taiwan's pharmacological screening technology is also well-known worldwide, and it is helpful to do efficacy evaluation tests.

Due to the small market in Taiwan and the small size of the manufacturers, the cost of research and development of new drugs is high. Many companies also seek international partners and prepare for entering the international market when new drugs are applied to enter Taiwan's clinical trial stage. Overall, new drugs for clinical trials in Taiwan are mainly cancer and cancer adjuvant therapy, followed by anti-infection, bone and joint and cardiovascular and cerebrovascular treatment. In the four stages of routine clinical trials, Taiwan currently applies phase II pharmacological trials for clinical trials, and a few Chinese new drugs can even enter phase III clinically.

With regard to the existing advantages of the above-mentioned Taiwanese traditional Chinese medicine industry, the cooperation between the two sides of the Taiwan Strait pharmaceutical industry in the Chinese medicine industry will gradually expand from the field of medicinal herbs by virtue of the signing of the "Straits Medical Cooperation Agreement." For mainland pharmaceutical companies, opening up the Taiwan pharmaceutical market is not a dream.