Business Club December 7th: Chinese medicine is a cultural treasure of the Chinese nation with thousands of years of history. It has been reported to Europe for hundreds of years. However, by April 1, 2011, Chinese medicine in Europe will encounter a historical choice that will either be completely destroyed by the military or will be completely underground. Professor Lin Guoming, chairman of the Belgian International Medical Center, said: “The situation is very critical. As of now, there has not been a case of successful registration of Chinese medicine in the European Union. From April 1st next year, Chinese medicine practitioners practicing medicine in Europe will face guns without bullets. That is, there is no embarrassment for traditional Chinese medicine."
On March 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 March 31, 2011. At present, most of the Chinese herbal medicines in the EU market are circulated in the form of food, health products, botanical raw materials or agricultural and sideline native products. However, the seven-year transition period is coming to an end and Chinese medicine has not yet been officially registered in the European Union. What are the reasons?
The European Union's "Regulations on Traditional Plant Drug Registration Procedures" stipulates that traditional herbal medicines "have at least 30 years of pharmaceutical history before the filing date, including at least 15 years of use history in the EU." Proof of the above-mentioned history of traditional application is based on publicly published literature, expert reports and customs records of import and export records also belong to the certification document. Professor Lin Guoming said: "Providing products with 15-year history in the EU market proves difficult." Some classic Chinese medicines that have been recorded in the Chinese Pharmacopoeia for more than 15 years, contain no toxic medicinal materials and are still widely used, such as Liu Wei Di Huang Wan, Wuji Baifeng Pills, etc., entered the EU 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. Before 2004, the customs records of Chinese medicine exports to EU countries were all registered according to the identity of foods rather than medicines. 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.
Second, high costs have deterred many businesses. According to reports, if a company’s Chinese medicine is registered in accordance with the “Regulations on Traditional Plant Drug Registration Proceduresâ€, the registration fee is approximately RMB 800,000. To pass the EU GMP certification, hardware investment such as production equipment requires RMB 4 million or more, and training is required. , expert guidance and other software investment also need 4 million yuan.
In spite of this, some Chinese companies are still actively working to secure the registration of their products in the European Union before the end of the seven-year transition period. It is reported that Chengdu Dioxinxuekang Capsule in Chengdu, Sichuan Province has passed the review of the Dutch drug administration department. The Dioxinxuekang capsule production line has also passed the EU GMP certification and is expected to become the first therapeutic Chinese proprietary drug product to enter the international market; Guangyao Group Qixing Pharmaceutical Acquired the project of simple registration of traditional British herbal products and GMP certification of EU (UK) Drugs; Lanzhou Foci "Lanshan" brand concentrated Angelica Pill has also been approved and formally accepted by Swedish National Drug Administration, and pre-assessment has also been passed. . However, before March 31, 2011, which of the three companies will take the lead in the EU to officially obtain legal status and make zero breakthrough in the legal sales of Chinese medicine in the EU, people will wait and see.
Professor Lin Guoming has traveled extensively in Europe and has practiced medicine for 20 years. He said: "In the face of such severe prospects, it is imperative that we work together to solve problems."
First of all, the practitioners of Chinese medicine in the EU should unite as one, not to displace each other. Followed by the Chinese medicine and patients in Europe should be jointly signed requirements for the legal status of Chinese medicine. Professor Lin Guoming said: “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. After March 31, 2011, Chinese medicine practitioners in Europe can contact their patients. The European Union politicians jointly demanded the legal status of traditional Chinese medicine, and it is believed that these politicians will not ignore the public’s voice.†The third is the role of the Chinese government. China is now the world’s second-largest economy. Its influence in the world is increasing. To save the fate of Chinese medicine in Europe, the Chinese government can play an irreplaceable role. Professor Lin Guoming believes that the Chinese government should work hard for Chinese medicine to achieve its legal status in Europe when conducting dialogues and negotiations at different levels with the EU and its member states.
Although the situation of Chinese medicine in Europe is quite dangerous, Professor Lin Guoming is not a pessimist. He said: "In the long run, I still have a more optimistic attitude towards the entry of Chinese medicine into Europe. Because Chinese medicine is superior in clinical treatment, it has a large number of people in Europe and there are many diseases that Western medicine cannot solve. Chinese medicine can handle it, and I believe that sooner or later, the Chinese medicine will break through the barriers set by the European Union's "Regulations for the Registration of Traditional Plant Drugs."
On March 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 March 31, 2011. At present, most of the Chinese herbal medicines in the EU market are circulated in the form of food, health products, botanical raw materials or agricultural and sideline native products. However, the seven-year transition period is coming to an end and Chinese medicine has not yet been officially registered in the European Union. What are the reasons?
The European Union's "Regulations on Traditional Plant Drug Registration Procedures" stipulates that traditional herbal medicines "have at least 30 years of pharmaceutical history before the filing date, including at least 15 years of use history in the EU." Proof of the above-mentioned history of traditional application is based on publicly published literature, expert reports and customs records of import and export records also belong to the certification document. Professor Lin Guoming said: "Providing products with 15-year history in the EU market proves difficult." Some classic Chinese medicines that have been recorded in the Chinese Pharmacopoeia for more than 15 years, contain no toxic medicinal materials and are still widely used, such as Liu Wei Di Huang Wan, Wuji Baifeng Pills, etc., entered the EU 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. Before 2004, the customs records of Chinese medicine exports to EU countries were all registered according to the identity of foods rather than medicines. 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.
Second, high costs have deterred many businesses. According to reports, if a company’s Chinese medicine is registered in accordance with the “Regulations on Traditional Plant Drug Registration Proceduresâ€, the registration fee is approximately RMB 800,000. To pass the EU GMP certification, hardware investment such as production equipment requires RMB 4 million or more, and training is required. , expert guidance and other software investment also need 4 million yuan.
In spite of this, some Chinese companies are still actively working to secure the registration of their products in the European Union before the end of the seven-year transition period. It is reported that Chengdu Dioxinxuekang Capsule in Chengdu, Sichuan Province has passed the review of the Dutch drug administration department. The Dioxinxuekang capsule production line has also passed the EU GMP certification and is expected to become the first therapeutic Chinese proprietary drug product to enter the international market; Guangyao Group Qixing Pharmaceutical Acquired the project of simple registration of traditional British herbal products and GMP certification of EU (UK) Drugs; Lanzhou Foci "Lanshan" brand concentrated Angelica Pill has also been approved and formally accepted by Swedish National Drug Administration, and pre-assessment has also been passed. . However, before March 31, 2011, which of the three companies will take the lead in the EU to officially obtain legal status and make zero breakthrough in the legal sales of Chinese medicine in the EU, people will wait and see.
Professor Lin Guoming has traveled extensively in Europe and has practiced medicine for 20 years. He said: "In the face of such severe prospects, it is imperative that we work together to solve problems."
First of all, the practitioners of Chinese medicine in the EU should unite as one, not to displace each other. Followed by the Chinese medicine and patients in Europe should be jointly signed requirements for the legal status of Chinese medicine. Professor Lin Guoming said: “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. After March 31, 2011, Chinese medicine practitioners in Europe can contact their patients. The European Union politicians jointly demanded the legal status of traditional Chinese medicine, and it is believed that these politicians will not ignore the public’s voice.†The third is the role of the Chinese government. China is now the world’s second-largest economy. Its influence in the world is increasing. To save the fate of Chinese medicine in Europe, the Chinese government can play an irreplaceable role. Professor Lin Guoming believes that the Chinese government should work hard for Chinese medicine to achieve its legal status in Europe when conducting dialogues and negotiations at different levels with the EU and its member states.
Although the situation of Chinese medicine in Europe is quite dangerous, Professor Lin Guoming is not a pessimist. He said: "In the long run, I still have a more optimistic attitude towards the entry of Chinese medicine into Europe. Because Chinese medicine is superior in clinical treatment, it has a large number of people in Europe and there are many diseases that Western medicine cannot solve. Chinese medicine can handle it, and I believe that sooner or later, the Chinese medicine will break through the barriers set by the European Union's "Regulations for the Registration of Traditional Plant Drugs."
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