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2011/6/8 14:26:00 49

First Registration Of Chinese Medicine Registration

During the 7 year grace period before the implementation of the EU Directive on traditional herbal medicine, no case was submitted to the Chinese medicine enterprise for registration, and was regarded as "internationalization retrogression of Chinese medicine" by the outside world, and this impasse was finally broken.

In June 1st, Lanzhou Fauci pharmaceuticals Limited by Share Ltd formally introduced the registration of Chinese medicine products to the Swedish National Drug Administration. This is the first time that Chinese patent medicines have been applied in the European Union.

Drug registration

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The application was submitted to foster pharmaceuticals in collaboration with Swedes, Sweden.

Pharmaceutical production

The concentrated Angelica pill.

"This is a unilateral variety, and the difficulty of declaration will be lower than that of the compound variety.

The Swedish company mainly provides consulting and plation services to us. "

In June 2nd, Sun Yu, the deputy general manager of Fauci pharmaceuticals, was responsible for overseas registration. In April of last year, the Fazi brand concentrated Angelica pill had passed the simplified registration pre assessment of the Swedish National Drug Administration, and became the first enterprise in China to pre evaluate the simplified registration of botanical and pharmaceutical products in the EU.

Due to the recognition of drug laws between EU Member States, if they can apply for registration successfully in Sweden, they will be able to obtain legal status in the mainstream market of EU medicine.

Sweden chose to be a registered country, Sun Yu explained. The Swedish people and the State Drug Law have a higher degree of acceptance of natural medicines and are more inclusive.

At present, including Tongrentang [34.26 -0.15% shares, several companies, including Guangyao group, are actively preparing to declare materials.

Among them, Tongrentang, the number one exporter of Chinese patent medicines, has chosen several varieties to carry out registration in a planned way.

For the past 7 years, no case of Chinese medicine passed the registration smoothly during the pition period.

Enterprise itself

The reason why the government and associations fail to play their due role is also an important reason.

In 2004, the EU promulgated the "traditional herbal medicine directive", which clearly stipulates that the traditional Chinese patent medicines can be sold through the European Union by simplifying registration and obtaining the status of drugs, which directing the sale of botanicals in the EU market for 7 years.

In April 30, 2011, the "traditional herbal instructions" was formally implemented.

But over the past 7 years, none of the Chinese pharmaceutical companies has been registered in the EU.

This means that starting from May 1st this year, unregistered plant drugs will be banned from sale.

In the EU market, Chinese medicines circulated in the status of food and health care products were forced to withdraw.

It has been reported that the sales volume of Chinese medicine enterprises in the EU market is not large, and the registration fee is very high, which is the main reason leading to the lack of initiative in the registration of Chinese medicine enterprises.

According to the data, China's Chinese patent medicine exports in 2010 are $180 million, while in the EU market, only $about 13000000