TCM Company Applies for EU Product License

A traditional Chinese medicine company based in northwest China’s Gansu province on Wednesday applied for a product license from the Swedish drug administration, becoming the first traditional Chinese medicine producer to apply for a license in a European Union (EU) country.

The Foci Pharmaceutical Company, based in the provincial capital of Lanzhou, is applying for authorization to produce a medication containing concentrated Chinese angelica, a type of Chinese herb, according to Sun Yu, the company’s deputy general manager.

“We hope Foci can become a pioneer in the industry and lead the way for other traditional Chinese medicine companies to work with the EU,” said Sun.
As the world’s biggest herbal medicine market, the EU has recorded annual herbal medicine sales worth about 10 billion euros, more than 40 percent of the world’s total.

The EU released the “Registration Process Order of Traditional Herbal Medicine” in March 2004, which stated that Chinese pharmaceutical companies would have to retreat from the EU market if their products weren’t registered in EU countries by April 2011.

So far, no Chinese firm has succeeded in obtaining a product license from an EU country.

However, Foci is expecting to succeed in its attempt because the company’s application is based on an extensive study of laws and regulations concerning drugs in EU countries, according to Zhu Zurong, the company’s general manager.

If the company’s medication is authorized in Sweden, it will be accepted by other EU countries as well, as the laws of EU nations are mutually recognizable, Zhu said.

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