Business Club April 18th With the deadline of the 7-year transitional period for the EU Directive on the Registration of Traditional Herbal Medicines (Herbal Medicine), China's Chinese medicine companies want to further expand their market in the EU, and they are struggling.

According to regulations, from April 30, 2004 to April 2011, traditional botanical drugs that have been marketed in EU member states can continue to be sold, and must be registered after the procedures specified in the “Directives” before they can be listed and sold. At present, there is no Chinese medicine product that has obtained the EU's drug approval. In this regard, the relevant person in charge of the Provincial Association of Chinese Medicinal Products Industry said that the European Union’s “ban on sales” has not yet affected the export of Chinese medicinal materials.

A single proprietary Chinese medicine costs about 1 million EU registration. The EU is the world's largest vegetable medicine market, with annual sales of 10 billion euros, accounting for more than 40% of the world's plant medicine market share.

Some TCM companies such as Beijing Tongrentang, Guangzhou Qixing and Foshan Fuci have submitted application materials to the EU, but so far no one company has passed simplified registration in the EU. In fact, no matter whether it is time or possibility, it is impossible for any domestic company to complete the registration.

This means that both Chinese companies and those engaged in the Chinese medicine industry in Europe will face operating risks and Chinese medicine exports to Europe may face penalties at any time. The data shows that the registration cost of a single proprietary Chinese medicine in the European Union is about 1 million yuan, and a traditional Chinese medicine company generally has more than one variety, and the application fee is relatively high. In addition, the registration requirements in the European Union are relatively high. Traditional Chinese medicine must have a medical history of at least 30 years before the filing date, including at least 15 years of use history in the European Union.

Zhejiang pharmaceutical companies "adopted ASEAN" to enter the European Union "Since the EU is not a major market in our province, the suspension of sales orders has no effect on the province's Chinese herbal medicine export enterprises." In this regard, the relevant person in charge of the Zhejiang Medicine and Health Products Import and Export Corporation Yao Zhai Li introduced that the main export market of our province is Asia. “Even if there is such a ban, we can still use the China-ASEAN free trade zone as a position. Pharmaceutical companies can export to the European Union through ASEAN and other places,” said a salesman at a pharmaceutical import and export company in the province.

Traditional Chinese medicine companies in the “old name” are calm. Sun Qun, Director of Hangzhou Huqing Yutang Office of President, said, “Chinese TCM companies failed to register, although there are factors such as higher application registration costs and negative corporate wait-and-see factors, but it is undeniable that this is related to the standardization of traditional Chinese medicine industry, traditional technology and marketing. There is a lag in the development of methods, etc. To make Chinese medicine 'to the world', the EU ban is still worthy of attention."