Europeans use traditional Chinese medicine as "medicine" and EU registration status is difficult to change

Business Club May 27th It is difficult to change the status of zero registration of Chinese medicine companies in the EU.

Kent Woods, director of the British Pharmaceutical Product Regulatory Authority, revealed yesterday in Shanghai that the high registration fees for drugs in the European Union will not be lowered for the time being, and the relevant implementation standards will not be adjusted.

From May 1st onwards, the European Union has begun to fully implement the "Traditional Plant Drugs Directive." Unregistered Chinese medicines will not be sold and used as medicines in the EU market. According to Wu Si, there are currently about 350 botanicals registered for registration, and more than 100 single Chinese herbal medicines have been registered. These are mainly products of European companies. As of now, there is no case of registration of Chinese medicines by Chinese companies.

In 2010, China's total exports of Chinese medicines to the European Union reached 250 million U.S. dollars, accounting for 14% of Chinese medicine exports. With such a huge market, why are Chinese companies standing on the list? According to Ni Rulin, president of the China Medicare Association, excessive registration "threshold" is the main reason for zero registration of Chinese medicine companies in China. Although the registration procedure in the Directive is somewhat simplified compared to Western medicine, many Chinese medicine companies are deterred by the fact that their requirements must have a proof of EU drug history over the past 15 years and a registration fee of several million dollars.

"The cost of registering a drug is about RMB 1 million. There are hundreds of products in our company. The cost is as high as you can imagine." Beijing Tong Ren Tang [33.20-0.54% share bar] Technology Development Co., Ltd. Deputy General Manager Guo Guiqin According to the disclosure, before 2004, Chinese exports of Chinese medicine are all channels for trade import and export companies. The declaration of pharmaceuticals will not list the details of drugs, and it will be difficult to come up with 15 years in the EU that meets the requirements of the directive. Use proof of record.

Wu Si said that there is no plan to reduce registration fees in the UK, and the main reason why European companies can register successfully is because they have a clear record of use. Wu Si said that in the future, the market is likely to have such a situation: A certain type of Chinese herbal medicines sold by registered companies are medicines, and the same products sold by Chinese companies are foods or health products.

In addition, Wu Si said that Chinese medicine has attracted attention in the United Kingdom in the past decade. The British Pharmacopoeia has also included more than 10 Chinese herbal medicines, including licorice, Chinese angelica, white peony and Phellodendron. However, few Europeans regard Chinese medicine as "medicine". (Author: Feng Yan)