Chinese medicine is facing full delisting risk in the European Union

The newspaper (Reporter Cui Fang), in accordance with the European Union's "Regulations on Registration of Traditional Plant Drugs," stipulates that starting from April, traditional plant drugs that do not meet relevant registration standards will be prohibited from selling within the European Union. In view of the fact that there has been no success in the “chongguan” of traditional Chinese medicines, Chinese medicines may be completely withdrawn from the market in the European Union. Chinese medicine practitioners in the European Union will face the situation of “no worries”.

It is understood that on March 31, 2004, the European Union promulgated the "Registration Procedures for Traditional Plant Drugs". The ordinance stipulates that all botanicals sold on the EU market must be registered under this new regulation and must be approved for marketing before they can continue to be sold. At the same time, the decree stipulates a seven-year transitional period allowing the sale of herbal products sold in EU countries in various capacities such as foods until March 31, 2011. Within the "7-year limit", products that want to remain in the EU market must meet the registration standards.

After the decree was enacted, some Chinese medicine companies actively worked hard. However, as of March 31 this year, there was still no "zero breakthrough" in the registration of Chinese medicines in accordance with the new regulations. According to relevant experts' analysis, there are two major problems faced by Chinese medicine “Chongguan”: First, the EU “Registration of Traditional Plant Drugs” stipulates that traditional herbal medicines registered for registration must provide at least 15 years of use history certification in the EU. . The classic Chinese patent medicines known and approved by EU patients, such as Liuwei Dihuang Pills and Wuji Baifeng Pills, entered the European Union market as early as 1995, but it is difficult to provide proof that European Union markets have a 15-year history of use. The second is that the registration fees are high and pharmaceutical companies are overwhelmed. According to reports, if a company's Chinese medicine is registered in accordance with the "Regulations for the Registration of Traditional Plant Drugs," the registration fee is approximately 800,000 yuan; to pass the EU GMP certification, hardware investment in production equipment and other needs need more than 4 million yuan; and training , expert guidance and other software investment also need 4 million yuan.

It is reported that the EU is the world's major plant medicine market, with annual sales of 10 billion euros. Although the 7-year period has passed, China is still actively fighting for the possibility of continuing applications. China's import and export of Chinese medicine related industry organizations called on the EU to extend the registration period to 2019.





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