Chinese medicine companies want to use WTO mechanism to strive for extension time

Business News Agency, May 16 For various reasons, during the “buffering period” of the previous seven years, there was no successful registration of Chinese medicine and it failed to qualify as a drug. This also means that Chinese medicine will not be sold and used as a medicine in the EU market. For the EU countries, they will also face the embarrassment of Chinese medicine without Chinese medicine.

However, there are also industry sources, China is using the WTO mechanism to negotiate with the EU, hoping to be able to postpone the transition period. Although the other party does not have a clear answer yet, according to the information available, the simple registration of this channel may continue and Chinese medicine is still expected to obtain legal status in the European Union.

There was no successful registration of a seven-year transitional Chinese medicine

On April 31, 2004, the European Union promulgated the "Directive of Traditional Plant Drug Registration Procedures." The directive stipulates that all botanical drugs sold on the EU market must be registered in accordance with this new regulation and must be approved for marketing before they can continue to be sold. At the same time, the directive stipulates a seven-year transitional period, allowing herbal products sold in European Union countries to be sold on April 31, 2011.

However, the seven-year time limit has been reached and none of the Chinese medicines have successfully passed the registration process, which means that the Chinese medicine will not be sold and used as a medicine in the EU market. For the EU countries, they will also face the embarrassment of Chinese medicine without Chinese medicine.

"If you charge according to the EU's official fees, the cost of registering a drug will reach 70,000 euros, and every EU market will have to register." A person in charge of a Guangzhou pharmaceutical company said that each company must be more than one In pharmaceutical products, the cost threshold for this move will probably increase by hundreds of times before the New Deal. Input and output cannot be directly proportional to the reasons why each Chinese medicine manufacturer has “do nothing”. "The proportion of our company's exports to the European Union is very low, and the proportion of exports to the Asian market, which is dominated by Korea and Japan, is even greater."

A person in charge of the Shenzhen Sanjiu Traditional Chinese Medicine Co., Ltd. said in an interview with reporters that the most important obstacle for the Chinese medicine to obtain its identity in the EU is that it is difficult to submit proof that it meets the registration requirements. According to the Directive, traditional herbal medicine application and registration requirements provide evidence that the product has a 30-year history of safe medicinal use, including at least 15 years of use in the European Community.

Prof. Lin Guoming, chairman of the Belgium International Medical Center, also said in an interview with reporters: “Providing products with 15 years of use history in the EU market proves difficult.” Some records in the Chinese Pharmacopoeia for more than 15 years and do not contain toxic medicinal materials. The widely used classical Chinese medicines, such as Liuwei Dihuang Pills and Wuji Baifeng Pills, have entered the European Union market as early as 1995. However, it is difficult to provide proof of the 15 years of use history in European Union countries, as well as 100-year-old stores like Rentang.

According to industry sources, before 2004, the customs records of Chinese medicine exports to EU countries were all registered according to the identity of the food, not the medicine. Moreover, before the year 2000, China Customs only required the application of a unified code for proprietary Chinese medicines or Chinese Herbal Pieces, and the company did not have a single variety of export records.

Liu Zhanglin, deputy director of the China Chamber of Commerce for the Import and Export of Medicines and Health Products, said: “The difference between China and the EU in GMP certification is also one of the reasons why Chinese medicines cannot be successfully registered. Chinese medicine companies must pass GMP certification, and Chinese pharmaceutical companies must also make more efforts.”

Obtaining legal status is more conducive to the internationalization of Chinese medicine

"In fact, the original intention of the European Union to enact the "Regulations on Traditional Plant Drug Registration Procedures" is to facilitate Chinese medicines to obtain the legal status of medicines and facilitate the opening of the Chinese medicine market by Chinese medicine," said Liu Zhanglin.

The introduction of Chinese medicine into Europe has a history of more than 300 years, but Chinese medicine has always been considered by the West as a synonym for acupuncture and moxibustion. Chinese herbal products have always entered the EU market in the name of food and pharmaceutical raw materials. This legislation undoubtedly has an important impact on the entry of Chinese medicine into the European Union. It not only affirms the use of Chinese medicine as a therapeutic drug for the first time, but also provides Chinese medicine with legal status in the European Union market and creates conditions for therapeutic drugs to enter Europe.

“Once a Chinese medicine is successfully registered, it will be eligible to enter the medical insurance system of EU countries, which will facilitate the export of Chinese medicine to the United States and other countries that have not yet recognized the identity of Chinese medicines.”

It is understood that the EU is the largest vegetable medicine market in the world, with annual sales of more than 10 billion euros, accounting for more than 40% of the world's market share of botanicals. It is China's second largest market for Chinese medicine outside of the Asian market. In 2007, the export of Chinese traditional medicine products exceeded the one billion US dollar mark for the first time.

In the EU system, the United Kingdom is China's main pharmaceutical trading partner. According to China's customs statistics, bilateral trade volume between China and the United Kingdom reached US$1.06 billion in 2007, an increase of 32% year-on-year. In that year, exports of Chinese medicines to the UK were US$19.75 million, of which Chinese herbal medicines and dried pieces exported US$4.06 million. Exports of 5.16 million US dollars, the United Kingdom has become China's major export destination of Chinese medicine products. According to British statistics, the annual market size of Chinese herbal medicine products has reached 150 million pounds.

In the seven-year transitional period of the "Regulations on the Registration of Traditional Plant Drugs", China has also had some Chinese herbal medicine manufacturers make efforts for the adoption of the traditional botanical drug registration procedures. Chengdu Dioxinxuekang Capsule in Chengdu, Sichuan Province passed the review of the Dutch drug administration department, and Dioxinxuexuekang capsule production line also passed the EU GMP certification; Guangyao Group Qixing Pharmaceutical was awarded the “simple registration of traditional British herbal products and EU (UK) drug GMP certification” project Projects.

However, it is a pity that up till now, there is still no Chinese herbal medicine manufacturer successfully completing the registration procedure for traditional herbal medicines. Liu Zhanglin stated that the Chinese medicine's legal status in the European Union is part of the process of internationalization of Chinese medicine. Although the countries currently exporting Chinese medicine are mainly Asian countries such as Japan and South Korea, the efficacy of traditional Chinese medicine has been recognized by many people in many countries. "Therefore, the prospect of Chinese medicine expanding into the international market should be very good. In the future, it should be more of a share of the European and American markets."

Experts give advice to pharmaceutical companies that Chinese medicine is expected to delay

For the future of Chinese medicine as a legal status of medicines in the European Union, Professor Lin Guoming, a renowned Chinese medicine doctor at the Belgian International Medical Center, also expressed positive opinions.

"In Europe, there are many people who rely on traditional Chinese medicine. EU member states are all democracies, and politicians value public opinion very much." For the sake of legal status for Chinese medicine, Lin Guomin suggests that Chinese medicine practitioners in Europe can contact their patients. The EU politicians wrote to ask for the legal status of Chinese medicine. "I believe these politicians will not ignore the public's voice."

Lin Guoming has been operating a Chinese medicine clinic in Brussels, the capital of Belgium, for more than 20 years. He said that most of the patients visiting his clinic are locals, and the Chinese only account for less than 10%. “Many local people regard Chinese traditional Chinese medicine as a symbol of profound Chinese culture. Many people came to admire it. After a long period of treatment, they gradually began to trust Chinese medicine.” He cited as an example a Belgian cancer patient he had treated. Traditional Chinese medicine has been used for a long time to prevent the condition from worsening. "Now I am worried about him. I can only advise him to go to countries outside the EU to buy Chinese medicine."

When talking about difficulties and obstacles in the successful registration of Chinese medicine for opening the EU market, Liu Zhanglin also proposed a good customs clearance strategy for Chinese medicine companies: First, companies must formulate long-term development plans and have plans to strategically enter the EU market; second, companies should Establish a dedicated team to address issues such as different EU and Chinese certification standards. Third, companies can establish cooperative relationships with customers in EU organizations. This will make it easier for Chinese pharmaceutical companies to enter the EU and register successfully.

“The China Chamber of Commerce for the Import and Export of Medicines and Health Products has already held consultations with the European Union through the Ministry of Commerce under the W TO mechanism and hopes to postpone it.” Liu Zhanglin revealed