CHENGDU -- 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.