The Foci Pharmaceutical Company, based in the city of Lanzhou in Gansu province, is applying for the Swedish drug administration to authorize one of its products, a pill-form of concentrated Chinese angelica.
As the world’s biggest herbal medicine market, the European Union has recorded an annual herbal medicine turnover of 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, ordering that Chinese pharmaceutical enterprises will have to retreat from the EU market if their patented medicinal products have not been 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 the laws and regulations on drugs in the EU countries, said Zhu Zurong, General Manager of the Foci Pharmaceutical Company.
“Accreditation procedures in Sweden are less strict than those of other EU countries, and the product chosen for this application is a kind of extract pill made from a single herbal ingredient, so the chemical composition and function of the drug is easily understood by foreigners,” Zhu said.
If the herbal pill 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.
The EU rules dictate that traditional herbal medicines cannot be licensed unless they have been in use for 30 years and have experienced a 15 year presence in the EU market.
However, many of the traditional Chinese medicines sold in the EU market were registered as “dietary supplements” rather than drugs at customs before 2004. Therefore, most of the pharmaceutical enterprises cannot provide valid evidence to prove the presence of their medicinal products in the EU market.
Meanwhile, to be licensed by EU countries, the enterprises will have to be able to introduce the exact chemical compositions and functions of medicinal products to the EU authorities.
“Traditional Chinese Medicine is an empirical science, which means the clinical efficacy and the chemical composition of the drugs can hardly be explained in scientific terms,” said Yang Yuhua, Director of the research and development center of the Foci Pharmaceutical Company.
Additionally, the registration application fees are too high for Chinese companies, Yang added.
Thorny as it is for these Chinese products to be removed from the EU market, the potential economic loss for Chinese firms delisting may be minimal since the primary markets for traditional Chinese medicine are the Chinese domestic and the Southeast Asian markets.
Traditional Chinese medicines recorded an export volume of $1.944 billion in 2010.
However, some experts worry that the potential delisting of the traditional Chinese medicine may lead to the unemployment of many traditional Chinese medicine practitioners in EU countries and European patients relying on traditional Chinese medicine will face a drug shortage.