Chinese medicine preparation is expected to return to the EU market

The reporter learned from the China Chamber of Commerce for the Import and Export of Medicines and Health Products that the Ministry of Commerce and the European Commission for Food Safety, Health, and Consumer Protection of the European Union Mission in China and the European Agency for the Evaluation of Pharmaceuticals (EMA) will join forces on October 11-13. Domestic Chinese medicine companies conduct a three-day training and information communication work to help return Chinese proprietary Chinese medicine products to the EU market.

According to reports, since April 30, 2011, the "EU Directive on Traditional Chinese Herbal Medicine Registration Procedures" has taken effect, the domestic Chinese medicine preparations are almost circulated, only Lanzhou Foci Pharmaceutical Co., Ltd., a concentrated Angelica pill has progress. The above measures of the European Union are regarded as the dawn of domestic companies. However, in the analysis of the industry, Chinese patent medicines are mostly compound and their composition is complex. The application process is still a long way to go.

EU experts and domestic companies zero distance communication

Luo Yang, director of the Chinese medicine and health products import and export trade association’s department of Chinese medicine, told reporters that the training exchanges on October 11th and 12th were held in Beijing and will be held in Chengdu on the 13th. Experts from China and the EU will in-depth interpret the “EU traditional herbal medicine”. "Registration Procedures Directive," which covers the interrelationships among the competent authorities of EU Member States, quality requirements for traditional herbal medicines containing multi-formulations, and the effectiveness and safety requirements of traditional herbal medicines, with a view to guiding Chinese medicine registration procedures in the EU. At the same time, domestic companies will also communicate with each other and share experiences.

According to reports, on March 31, 2004, the European Union promulgated the "Directive of Traditional Plant Drug Registration Procedures." The directive stipulates that all botanical drugs sold on the EU market must be registered in accordance with this new regulation and must be approved for marketing before they can continue to be sold. At the same time, the directive stipulates a seven-year transitional period, allowing herbal products sold in European Union countries to be sold on March 31, 2011. Luo Yang said that in fact, since 2004, domestic companies began to do their homework for returning to the EU market, and there is no lack of understanding of the relevant directives. The main role of training is for domestic and foreign and domestic companies. Sharing experience platform.

Japanese and Korean companies also face the same problem

Guo Fanli, a researcher in the pharmaceutical industry of China Investment Advisors, analyzed that the training benefited from the vigorous efforts of the domestic pharmaceutical industry associations and the Ministry of Commerce. As early as April of this year, the Ministry of Commerce went to Europe with the Chinese Medicine Association to negotiate with the EU. With this series of negotiations, the training guidance for Chinese medicine companies was realized. There is also that the EU does not want Chinese medicines to withdraw from its medical market because the inability of Chinese medicines to enter the EU market has caused the plight of doctors who have no medicine to use.

Luo Yang also emphasized that it is difficult for domestically produced Chinese medicine products to enter the EU market. However, the EU does not want to see this. The EU Directive on Traditional Herbal Drug Registration Procedures is not only aimed at domestically produced products. Traditional Chinese medicine preparations in Japan, South Korea and Asia are also facing The same problem, "So far, successfully obtained products registered by the EU are still European."

Unilateral applications are easy to pass but only a few products benefit

According to the website of the State Administration of Traditional Chinese Medicine, Lanzhou Foci Pharmaceutical Co., Ltd. took the lead in the implementation of the “European Traditional Herbal Drugs Registration Procedure Directive”. National Drug Administration. If the application for registration is successful, it will be the first Chinese medicine preparation to obtain the legal identity of the EU pharmaceutical market as a drug.

Concentrated Angelica Pills are unilateral varieties, and the application difficulty is relatively lower than that of compound varieties, but Luo Yang admits that Chinese patent medicines feature compound prescriptions and that unilateral products only account for a minority, so most proprietary Chinese medicines are still facing more difficult situations. Yuan Kelun, director of the Guangzhou Qixing Pharmaceutical Marketing Center, who has been working hard to enter the EU market, said that the slow progress of applications, the company's rhinitis tablets are compound, various components interact with each other, interference factors, compared to the single product Difficulty.

In addition, Luo Yang said that the "EU Directive on Traditional Herbal Drug Registration Procedures" mainly targeted Chinese medicine products, such as Chinese Herbal Medicine and other products have not been affected. The analysis report from the China Chamber of Commerce for Import and Export of Medicines and Health Products shows that in recent years, the natural medicine market in Europe and the United States has become increasingly prosperous, and the consumption has been expanding year by year. In the first half of 2011, China’s export of traditional Chinese medicine to the European and American markets (mainly the growth of health products and extracts) Faster) Exports increased significantly year-on-year, of which exports to Europe increased by 77% year-on-year. In the first half of the year, China’s exports of European extracts increased by 86% year-on-year, of which exports to Germany increased by 134%.