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Jan
15

A leading pharmaceutical firm that produces traditional Chinese medicine in the northwestern Gansu Province is hoping to make Sweden its gateway to the European Union market after a landmark EU directive on herbal drugs takes effect in 15 months.

    ”We have applied to export our medicine to Sweden and eventually other EU markets,” said Sun Yu, deputy general manager of Foci Pharmaceuticals based in Lanzhou, the provincial capital.

    Sun said Friday he saw a ray of hope in a two-hour visit by Dr. Magnus Breidne, science counselor of the Swedish Embassy in China and Christina Chuck, general manager of the Stockholm-based Wilkris & Co, to his workshops on Thursday.

    Foci Pharmaceuticals, founded in 1929, has been selling herb extracted pills to 27 countries and regions including the United States, Canada, Japan, Germany, the Netherlands and Australia.

    It is China’s largest exporter of herbal products in terms of volume and number of destinations. But like all other Chinese herbal exporters, its pills are categorized as “food” or “healthcare products” instead of “drug” in the international market.

    EU’s Traditional Herbal Medicinal Products Directive, issued in2004, however, requires all herbal medicine products to obtain an authorization to market within the EU starting in April 2011.

    The directive requires evidence proving 30 years’ use — of which 15 years must be in the EU community, to ensure safety.

    ”If we cannot obtain the authorization, our products will be taken off the shelves in EU next year,” said Sun Yu. “It’ll be a great loss for the Chinese industry as well as our European buyers who are relying on Chinese herbal medicine to keep fit.”

    As the only herbal pharmacy in China to have 15 years of presence in the EU, Sun said his company was still the most hopeful to cross the barrier. “There’s a technical, as well as a cultural, barrier to get over.”

    Foci failed to be accredited for sale in Britain in 2006. “We are hoping to enter the Swedish market, where the accreditation procedures are less strict,” said Sun.

    His company has applied for authorization of 10 product categories to be sold to Sweden. “We hope one or two will make it in the coming 15 months.”

    Dr. Breidne said the Swedes were not very familiar with herbal medicine. “But I suppose they will be quite interested.”

    Twenty years ago the Europeans had no idea about Chinese acupuncture. “Today, it’s popular among many women,” she said.

    While most Swedish thought herbal medicine might, to some extent, prevent illnesses, it still needed time and research to prove that the herbs were really effective and safe, she added.

    Chuck, from an industry insider’s perspective, suggested Chinese companies should study the international market from the westerners’ standpoint. “It’s also necessary to mark clearly the products’ ingredients and side effects, which are sometimes not listed properly in herbal medicine from China.”

    China exported 193 million U.S. dollars worth of herbal medicine to the EU in 2008, the most recent data available from the General Administration of Customs.

    The State Food and Drug Administration is working to enhance foreign exchanges and cooperation in the accreditation and authorization of traditional Chinese medicine in other countries, said Zhang Wei, an official in charge of drug accreditation.

    ”We’ll try to build a platform for traditional herbal medicine to enter the EU market,” he said.

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