EU new regulations on botanical drugs come into effect

A paper of instructions made Chinese medicine suppliers and EU purchasers at the 109th Canton Fair uneasy The two sides did not rush to place an order, but more just met to discuss countermeasures The directive on the registration procedure of traditional botanical drugs (hereinafter referred to as the directive) issued by the European Union in 2004 was formally implemented on May 1 this year According to the directive, all pharmaceutical manufacturers must complete registration before April 30, 2011, otherwise they are not allowed to sell and use in the EU Industry insiders said that at present, no Chinese patent medicine product in China has been approved by the European Union The reason is that the technical data required by the European Union involves the problem of Chinese patent medicine standards, and there are qualitative and quantitative index requirements for ingredients, which is just the short board of compound Chinese patent medicine The implementation of the directive coincides with the opening of the third phase of the Canton Fair At the peak of the export order receiving period, domestic Chinese medicine enterprises encounter the above problems, and many enterprises say they dare not take orders rashly As of May 2, the intentional turnover of Chinese patent medicines in this Canton Fair is only over US $5 million, and some of them will enter the EU market as "health products" In view of the uncertain situation, some Chinese medicine enterprises have increased their efforts to explore other markets Dong Ling, regional manager of Beijing Tongrentang (600085) International Co., Ltd., told the first financial daily that there are still European customers coming to negotiate at the fair, but there is no deal for orders of traditional Chinese medicine In recent days, the trading of Chinese patent medicines in the EU region at the Canton Fair has been cold Large domestic traditional Chinese medicine enterprises such as Tianjin ZHONGXIN PHARMACEUTICAL (600329) have only a few orders for Chinese patent medicines in the EU region Xiao Jun, manager of Foreign Trade Department of Wuhan guomoxibustion Technology Development Co., Ltd., pointed out that some EU agents of the company were about to be out of stock and the two sides were looking for solutions Not only drugs, but also vegetable medicine products sold in the way of food in many European countries are strictly limited Wang Yonggang, manager of Shenzhen Sanjiu traditional Chinese medicine Investment Development Co., Ltd., said that any plant medicine produced by extracting medicinal ingredients from plants would be classified as drugs, so it is difficult for traditional Chinese medicine to enter the European market through food or health care product registration To this end, while consolidating the traditional overseas markets of traditional Chinese medicine such as Southeast Asia and Australia, the company is also increasing the development of the North American market However, the reporter learned at the Canton Fair that some traditional Chinese medicines can still enter the EU market as "health products" Chen Kang, director of the general manager's office of Shanghai Medical and health products import and Export Co., Ltd., said that at present, raw herbs and some health products have not been greatly affected EU purchasers continue to place orders for such products at the Canton Fair The risk of nutritional health products entering the EU market is smaller than that of functional health products "Many traditional Chinese medicine production factories are unable to bear the increased cost of registration From the current situation, the impact of the directive on traditional Chinese medicine production factories is greater than that of foreign trade companies, which are relatively flexible and can adjust product varieties according to market conditions." Chen Kang said At the end of 2010, domestic enterprises such as Beijing Tongrentang, Guangzhou Qixing Pharmaceutical Co., Ltd and Lanzhou foci Pharmaceutical Co., Ltd started to apply for EU registration However, due to the large registration cost and the difficulty in crossing the relevant technical barriers, there is still no case of Chinese patent medicine registered as a drug in the EU Liu Zhanglin, vice president of the chamber of Commerce for the import and export of health care products of China Pharmaceutical (600056), told our reporter that although the chamber of Commerce has been constantly communicating with the pharmaceutical regulatory authorities of major countries in the EU region, trying to extend the effective time limit of the EU directive for Chinese enterprises, it is difficult to promote foreign legislation Zong Jinbo, head of Sweden's China Pharmaceutical Group, said that in the future, the development of traditional Chinese medicine in Europe will probably fall into a difficult situation of "with or without medicine" The implementation of the directive will also have an impact on the development of EU traditional Chinese medicine industry It is reported that nearly 100000 TCM practitioners in the EU are in danger of transformation or unemployment, including local TCM agents.