China's proprietary Chinese medicine exports account for only 0.5% of the EU market

Business Club April 19th With the deadline of the 7-year transitional period for the EU Directive on the Registration of Traditional Plant Herbal Medicines (Herbal Medicine), China's Chinese medicine companies want to further expand their market in the EU and appear to be 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.

The EU is one of the world's largest vegetable drug markets, accounting for approximately 40% of the world's market share of botanicals, and has attracted many Chinese medicine companies. However, in the past seven years, China has not yet registered a successful Chinese medicine company in the European Union, breaking the record. Faced with many “high thresholds” set by the EU, it is still unknown whether companies can successfully sprint in the final stage.

Liu Zhanglin, vice president of the Health Products Import and Export Chamber of Commerce, said in an interview with reporters that Chinese medicine must have more than 30 years of medicinal history before the EU registration application date and at least 15 years of use in the European Union. Since most Chinese medicines enter the EU market with “identity” such as dietary supplements and health products, many Chinese medicine companies cannot obtain sales certifications for certain products. Currently there are only about 100 kinds of Chinese medicines that can be used in the EU for 15 years.

In addition, the reporter learned that Chinese medicine companies want to obtain registration qualifications in the EU market, but also face high costs.

An industry source told reporters that in accordance with EU regulations, the registration cost of a single proprietary Chinese medicine is about 1 million yuan, and a traditional Chinese medicine company generally has more than one variety, plus a subsequent GMP (Pharmaceutical Production Quality Management Specification) certification fee. And hardware investment will be a large cost expenditure.

"This is inconsistent with the market performance of most domestic Chinese medicine companies. With the recent frequent price increases of Chinese herbal medicines, business pressure has doubled," said Zhao Bing, an analyst in the pharmaceutical industry.

Guo Fanli, a research fellow in the pharmaceutical industry, also pointed out that in addition to meeting the aforementioned "hard targets," Chinese medicine companies still face and overcome some "soft indicators", such as differences in international cultural backgrounds, local residents' recognition and acceptance of Chinese medical treatment effects, and so on.

In fact, the EU is not the main market for Chinese proprietary Chinese medicine exports. In 2010, China’s exports of Chinese patent medicines to the EU were approximately US$10 million, accounting for only 0.5%. However, the embarrassment encountered by Chinese medicine companies in the EU market has once again refuted the fact that Chinese medicine companies and their products are in a weak position internationally.

“For a long time, Chinese proprietary Chinese medicines have often been rejected due to their inability to explain their ingredients and pharmacological effects to foreigners. In addition, domestic GMP is not yet in line with international standards, which has caused enterprises to face barriers in going abroad,” said Guo Fanli.

Li Jizon, head of the promotion department of the Shanghai Center for the Promotion of Chinese Medicine Science and Technology Industry, also stated that although China’s share of trade exports to the EU market is low, this “registration order” will have a limited impact on the domestic Chinese medicine market in the short term, but pharmaceutical companies are on the way to sea. There are many challenges and pressures.

Li Jizon suggested that enterprises can gradually increase their cooperation with overseas pharmaceutical companies and gradually become familiar with the operating procedures and characteristics of overseas markets. After these markets mature, the introduction of products will have better results.

In addition, some experts suggested that domestic pharmaceutical companies step up efforts to improve internal strength, improve product quality and market competitiveness, and earnestly study and analyze the history, culture and laws of various countries, and know each other.

It is worth mentioning that although European Union law stipulates that unregistered plant drug products will no longer be able to be sold on the EU market under other names (such as food additives, health foods, etc.) after the transition period, it is currently the import and export of Chinese medicine and health products. According to the understanding of the EU's relevant departments, the Chamber of Commerce has not yet defined and divided the EU strictly.

“Because of the diversity of functions of many plant products, which can be used as food additives, they can also be used for medicines. Which products should be included in what kind of channels for management are generally determined by member states according to relevant laws and regulations, if the member states If it is determined that the product is a drug, the product cannot be sold in other names," said Liu Zhanglin. Therefore, it remains to be seen where Chinese medicines go in the EU market.

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