Chinese medicine preparations are expected to return to the EU market

Business news agency, September 27 (Xinhua) -- China Chamber of Commerce for the import and export of pharmaceutical and health care products (cmhp) learned recently that from October 11 to 13, the Ministry of Commerce, the General Department of food safety, health and consumer protection of the European Union mission in China, and the European drug review Administration (EMA) will jointly carry out a three-day training and information communication work for domestic traditional Chinese medicine enterprises to help Chinese patent medicine products return to the EU market According to reports, since the EU traditional herbal medicine registration procedure directive came into force on April 30, 2011, almost all Chinese herbal preparations have been handed in blank, and only the concentrated Angelica pill of Lanzhou foci Pharmaceutical Co., Ltd has made progress The above measures of EU are regarded as the dawn of domestic enterprises However, according to industry analysis, Chinese patent medicines are mostly compound, with complex ingredients, and the application road is still a long way to go Zero distance communication between EU experts and domestic enterprises Luo Yang, director of the traditional Chinese Medicine Department of the China Chamber of Commerce for the import and export of healthcare products, told reporters that the training exchange was held in Beijing on October 11 and 12, and was held in Chengdu on October 13 At that time, experts from China and the European Union will deeply interpret the EU traditional herbal medicine registration procedure directive, which covers the relationship between the competent authorities of EU Member States and the quality of traditional herbal medicine products with multi formula Quantity requirements, effectiveness and safety requirements of traditional Chinese medicine, etc are expected to guide the registration process of traditional Chinese medicine in the EU Meanwhile, domestic enterprises will also exchange experiences with each other According to reports, on March 31, 2004, the European Union promulgated the directive on the registration procedure of traditional botanical drugs According to the directive, all botanical drugs sold in the EU market must be registered in accordance with the new regulation and can only be sold after being approved for marketing At the same time, the Directive provides a seven-year transition period, allowing the sale of herbal products sold in EU countries in various capacities, such as food, until March 31, 2011 In fact, domestic enterprises have been doing homework for returning to the EU market since 2004 They do not lack understanding of relevant directives The main role of training is to provide a platform for domestic and foreign enterprises to exchange and share experiences with each other Japanese and Korean enterprises face the same problem Guo Fanli, a researcher in the pharmaceutical industry of CIC, said that the training benefited from the efforts of the domestic pharmaceutical industry association and the Ministry of Commerce As early as April this year, the Ministry of Commerce and the domestic pharmaceutical association went to Europe to negotiate with the European Union With such a series of negotiations, the training and guidance for traditional Chinese medicine enterprises was realized In addition, the European Union does not want Chinese medicine to withdraw from its medical market, because the inability of Chinese medicine to enter the European market has resulted in the dilemma that doctors have no medicine available Luo Yang also stressed that it is difficult for domestic traditional Chinese medicine products to enter the EU market, but the EU does not want to see this scene The EU traditional herbal medicine registration procedure directive is not only for domestic products, but also for Japanese, Korean and Asian traditional Chinese medicine products "Until now, the products successfully registered in the EU are all European products " According to the website of the State Administration of traditional Chinese medicine, after the EU traditional herbal medicine registration procedure directive came into force, Lanzhou foci Pharmaceutical Co., Ltd officially submitted the application materials of European Union traditional herbal medicine simplified registration ECD of concentrated Angelica pill to the Swedish National Drug Administration on May 31, 2011 If the application for registration is successful, it will be the first Chinese medicine preparation in China to obtain legal status in the EU pharmaceutical market as a drug Concentrated Angelica pill belongs to one-sided varieties, and the difficulty of application is relatively lower than that of compound varieties However, Luo Yang said frankly that Chinese patent medicine is characterized by compound drugs, and only a few single products, so most Chinese patent medicines still face a difficult situation Yuan Kelun, director of marketing center of Guangzhou Qixing Pharmaceutical Co., Ltd., who has been working hard to enter the EU market, said that the application progress is slow, the company's Biyan tablet is a compound, and various ingredients affect each other, with many interference factors, which is more difficult than a single product In addition, Luo Yang said that the EU traditional herbal medicine registration procedure directive mainly targets Chinese patent medicine products, and other products such as Chinese herbal pieces are not affected by this The analysis report from China Chamber of Commerce for the import and export of health care products shows that in recent years, the natural drug market in Europe and the United States has become more and more prosperous, and the consumption has been increasing year by year In the first half of 2011, the export of traditional Chinese medicine (mainly health care products and extracts) to the European and American market increased significantly year on year, of which the export to Europe increased by 77% year on year In the first half of this year, China's export of extracts to Europe increased by 86% year on year, of which the export to Germany increased by 134%.