European Union's traditional herbal medicine registration directive brings opportunities for the internationalization of Chinese medicine

Business Club July 11 How to make proprietary Chinese medicines registered through the EU and enter the local mainstream pharmaceutical market as pharmaceuticals and sell them to Europeans?

Scholars, representatives of enterprises and relevant government officials of the Chinese medicine community in China recently concentrated on discussing this issue in Lanzhou City, Gansu Province, in the northwestern province of China, in order to further promote the internationalization of the Chinese national treasure.

Gansu is the largest province in China for artificially planting Chinese herbal medicines, with an area of ​​2.5 million mu. Lanzhou Foci Pharmaceutical Co., Ltd., an old Chinese medicine company in the province, submitted a registration application for Chinese patent medicine to the Swedish National Drug Administration in June this year and was accepted. This is the first time that Chinese patent medicines have applied for registration of drugs in the European Union.

In 2004, the European Union announced the "EU's Traditional Herbal Registration Directive," which stipulated the "simple registration" procedure and set a seven-year sales transition period for the herbal medicines currently in use in the European Union. On April 30 this year, the seven-year transition period expired and this directive was formally implemented.

Foci Pharmaceuticals applied for registration of drugs to the European Union, which triggered the attention of the Chinese medicine community in the EU registration of Chinese medicines. While the media is concerned about the success of the registration of Foci Cilic Pharmaceuticals, it is also asking why there has been no case of registration of Chinese medicines through the European Union in the past 7 years of transition.

Wang Guoqiang, Director of the State Administration of Traditional Chinese Medicine of China, said: “Because there is no successful registration of proprietary Chinese medicines in the European Union, Chinese patent medicines will not be able to continue to be sold in the EU in the short term. However, the larger export share of extracts and extracts can still be food or food supplements. Formal sales."

Previously, Chinese patent medicines, like traditional Chinese medicines and traditional Chinese medicine extracts, were all used as “food and food supplements” sold in the EU.

Due to the lack of recognition of drug identities and the inability to enter the mainstream pharmaceutical market, the share of proprietary Chinese medicines in the EU market has been very small. According to Wang Guoqiang, in 2010, the export volume of Chinese medicine to Europe was 250 million U.S. dollars, of which Chinese patent medicine accounted for only 4 percent, and it was about 10 million U.S. dollars.

Despite the fact that for the past 7 years, no Chinese medicine has registered with the EU drugs for various reasons, people in the Chinese medicine community who come to Lanzhou to negotiate EU registration policies for Chinese medicine believe that the EU's traditional herbal medicine registration directive objectively accelerates the internationalization of Chinese medicine. The pace provides opportunities.

Wang Guoqiang said that the “simple registration” procedure stipulated in the new directive greatly increased the possibility of registration sales of proprietary Chinese medicines in the form of pharmaceuticals compared to the requirements of the “EC Registration Directive for Human Use of Medicines”. Formal access to the EU market provides the opportunity.

At present, the EU is considered to be the largest plant medicine market in the world except China. The registration of Chinese medicines on the surface of the European Union is a recognition of the identity of drugs, and behind it is a potentially huge market.

Sun Yu, deputy general manager of Foci Pharmaceuticals, said that if Foci Ciwei Chinese medicine can be registered through the EU, enter the formal drug channel sales and open the market, it is expected that its sales can exceed the current total exports of Chinese proprietary Chinese medicine to Europe.

In addition, the global concern of American botanicals has been deeply influenced by Europe in drug research, management, and marketing. Those who participate in the EU's EU registration consultation generally believe that successful EU registration will open the door for Chinese medicines to enter the US market, and will have a positive and far-reaching impact on future sales in North America and the world.

“Traditional Chinese medicine is going to the world and entering the international market is an inevitable trend of development.” Wang Xiaode, an academician of the Chinese Academy of Engineering, said, “Whether Chinese medicines can gain access to markets in Europe and the United States as pharmaceuticals and enter the international market is one of the key issues in the internationalization of Chinese medicine. Is also our focus of long-term attention."

Sun Yu said that if the registration is successful in the EU, Foci Pharmaceuticals will not only set up a sales center in the EU, but also organize Chinese medicine experts to exchange academics, train sales personnel, and promote Chinese medicine. This will undoubtedly benefit the internationalization of Chinese medicine.

Although the EU's Traditional Herbal Medicine Registration Directive provides an opportunity for Chinese medicines to enter the EU market in the form of pharmaceuticals, more Chinese medicines, especially complex Chinese herbal medicines, are registered in the European Union and entered the mainstream pharmaceutical market as pharmaceuticals. The challenge is still very high. Big, the road is still long.

Zhu Rongzu, general manager of Foci Pharmaceuticals, said that it is not an easy task to tell Europeans how effective Chinese medicine is, whether it is safe or not, and it requires a huge amount of scientific research, which takes a lot of manpower and financial resources, and it is also a great risk. Why is there not one case of registration of Chinese medicines through the EU in the past seven years?

However, Foci Pharmaceuticals, which has accumulated experience, is now expected to achieve a zero breakthrough in the EU registration of Chinese medicine.

Sun Yu admits that competition in the domestic market has become increasingly fierce, and the price of finished medicine has been difficult to rise, while the cost of raw materials, labor, and transportation is constantly rising, and there is more room to go abroad. For example, if Foci applied for the EU-registered drug, the ex-factory price is still five years ago, and raw material prices have already doubled.

Participation in discussions with Chinese medicine practitioners who discuss Chinese medicine registration policies in the Chinese medicine industry believes that promoting the internationalization of Chinese medicine is conducive to the upgrading of the entire industry, and the upgrading of the industry can make Chinese medicine better to the world. In this interactive process, in addition to the enterprise's own efforts, the government should also give active support.

Wang Yude said that currently China's exports of Chinese medicine products are still dominated by low value-added raw material products such as Chinese herbal medicines, decoction pieces, and plant extracts, which are extremely disproportionate to China’s thousands of years of TCM tradition and the status of a major Chinese medicine resource. We look forward to using the opportunity provided by the new EU Directive to realize the return of the traditional Chinese medicine brand in the international market and its due value. (Reporter Zhu Guoliang)