CHENGDU, May 8 (Xinhua) -- As a brand-name herbal capsule for cardiovascular disease in China, Di'ao Xinxuekang only needs to wait for another 15 years before reaching the EU market.
"The Dutch medical supervisors have recognized it as a qualified drug, but we still lack the evidence of 15-year presence in the EU market," said Ji Jianxin, a research manager with the drug's developer Di'ao Group based in southwest China's Sichuan Province.
Di'ao, one of the largest Traditional Chinese Medicine (TCM) manufacturers, has been quite depressed, as many other TCM enterprises in China, by a European Union directive on traditional herbal medicinal products fully implemented from the beginning of this month.
The directive requires that all herbal medicinal products, must obtain a medical license from any EU member state before it can be allowed in the EU market.
It introduced a so-called simplified registration procedure with a seven-year transition period for traditional herbal medicinal products to be licensed, including Chinese and Indian ones.
However, not a single Chinese herbal medicinal product has been granted the license so far, mainly due to the prohibitive registration cost and lack of required evidence to prove the product had a 30-year history of safe use, including 15 years in the EU.
With a history of more than 2,000 years, TCM did not enter into the EU market until mid-1990s, and it has been imported into the EU and sold to European customers as food supplements instead of drugs.
Most Chinese producers and importers did not reserve the customs papers a decade ago, thus unable to prove the 15-year use of their products in European markets.
While TCM's globalization won't be doomed by one single EU directive as TCM export value to EU only takes up 14 percent of the total in 2010, experts and industry insiders still have had serious concerns about its future.
"Most TCM even don't have standardized labels that can help consumers to find out its origin," said Xian Sheng, from the China Association of TCM Export Companies.
Many experts interviewed by Xinhua said the cultural and philosophical difference could be the greatest barrier to TCM' s entering into western market.
"TCM prescriptions seem confusing to the west with no specified amount of ingredients, while western medicine always pursues accuracy in medical quantity and composition," said Lai Xiaoping, director of pharmaceutical science with Guangzhou University of Chinese Medicine.
Therefore, TCM needs a lot more strategies for its overseas promotion, industry insiders say.
China has signed 91 government contracts with 70 countries to cooperate in the general medical sector, plus 48 contracts exclusively concerned with TCM, according to Peng Yuhang, an official with Sichuan's science and technology department.
"Our government can have a big role to play in promoting TCM in the global market, said Wang Deqin, a manager from a Guangzhou-based TCM company.
"The Republic of Korea has sent government delegates to promote its ginseng in China. We should learn from their publicity strategies," Wang said.
Professor Lin Bin, director of a TCM clinic in the Netherlands, suggested that China's domestic TCM companies generate long-term vision and cooperate with local competitors, as well as establish partnerships with prestigious European medical institutions specializing in research and development.
In fact, some companies have got the benefits of local partnerships. A Guangzhou-based pharmaceutical company obtained a drug license from medical authorities in the Republic of Belarus following a clinic project in cooperation with local medicine research institutions.
Experts have also called for the unity of all TCM companies as collective strength to explore the global market together.
The revenue of global herbal products has been increasing by 10-20 percent every year, but China's TCM only takes up about 3 percent of the global market, and 70 percent of its exports are raw herbs with much less added value.
"We still have a long way to go global, and most importantly, we need to pull our efforts together," Xian said.