Business Club April 25th Recently, discussions on Chinese medicine and the EU market are escalating. Due to the European Union's "Regulations on Traditional Plant Drugs Registration Procedures" issued in 2004, the directive states that if products cannot be registered before April 30, 2011, they will not be sold and used in the EU. Today, the deadline is approaching. No Chinese medicine company has yet to obtain an access permit.
As the world's largest vegetable medicine market, the EU market has reached 10 billion euros, accounting for more than 40% of the world's plant medicine market share. Data from the China Chamber of Commerce for the Import and Export of Medicines and Health Products shows that from January to February 2011, the number of Chinese herbal products exported to the European Union was 4,845,961 kilograms, and the export value was 60.392 million US dollars, accounting for 17.6% of the total export volume of Chinese medicines. These data can show that the EU market is not insignificant for Chinese TCM companies.
The remaining deadlines are numbered. Did thousands of Chinese medicine companies have been rejected by the EU since then? According to industry insiders, the EU market has an objective capacity and Chinese companies should not give up. “At present, though temporarily blocked, the door to EU certification has not been closed, and there are still many opportunities for active response.”
Chong Guan meets resistance is to enter or retreat?
“Although some domestic Chinese medicine companies have submitted application materials to the EU, due to various reasons, there is still no one company that has simplified the registration through the EU's “Regulations on Traditional Plant Drug Registration Procedures.” Liu Zhanglin, vice president of the China Chamber of Commerce for the Import and Export of Medicines and Health Products, told reporter.
According to the reporter's understanding, before this, Lanzhou Foci "Lushan" brand concentrated angelica pill has passed the pre-assessment of the Swedish National Drug Administration; Guangyao Group Qixing Pharmaceutical won the "simple registration of British traditional herbal products and EU (UK) drug GMP "Certification" project project. In addition, Beijing Tong Ren Tang has been actively preparing relevant registration information. Why hasn't even one family succeeded so far? Is the EU market really a monolith for Chinese companies?
The "Regulations on Traditional Plant Drug Registration Procedures" stipulates that traditional herbs "have at least 30 years of medicinal history before the date of application, including at least 15 years of use history in the European Union". Yuan Kelun, director of Qixing Pharmaceutical Marketing Center, told reporters that Guanghan Pharmaceutical Group Baiyunshan and Huang, Zhongyi, Qixing, Xingqun, Pangaoshou, Wanglaoji and many other corporate products have been sold in Europe for many years, and some have exceeded 15 years. However, most of the products of these companies are sold in the form of food or health products. There are neither drug identities nor channels through agents. The companies themselves cannot produce valid sales certificates.
A person in charge of a Guangdong-based Chinese medicine company told reporters that the sale of its own Chinese medicine in the European Union is very small, not only does not meet the requirements for the use of years, but also to consider the registration fee of up to a single product 1 million yuan, "input and output are not worthwhile, or "Abandoned." Li Xingliang, general manager of Qixing Pharmaceuticals, stated that in addition to the registration fee of RMB 1 million for a single product, companies must also expend more marginal costs such as related pharmacological studies.
At the same time, the difference in technical standards is also the “Kan Er” that can be bypassed by traditional Chinese medicine companies. In 2009, Guangzhou Qixing selected the United Kingdom as a certification and registration country to implement the "EU GMP certification and herbal medicine registration" project. Yuan Kelun introduced that the registration of Qixing in the EU market is divided into two steps: First, through the European Union cGMP certification; Second, choose the type of tablet or pill to apply for registration. “The company has applied for registration of rhinitis tablets. The registration work has been carried out for more than two years. It is mainly to carry out the qualitative and quantitative stability study of the product. According to his analysis, the key point of simple registration of EU herbal products is to require each of the product group's A medicinal material must have quantitative control of ingredients and be relatively stable within the validity period. “This aspect is the shortcoming of proprietary Chinese medicines, and basic research needs to be done. It is difficult to control the timing.” Yuan Kelun said that Qixing’s investment in the entire certification project has reached several million yuan.
Sun Yu, deputy general manager of Lanzhou Foci Pharmaceuticals Co., Ltd., also believes that the technical documents submitted by the European Union concern the issue of proprietary Chinese medicines, and that the qualitative and quantitative indicator requirements for ingredients are indeed the weaknesses of traditional Chinese patent medicines. Sun Yu explained that because the management of botanical drugs in EU countries was not uniform and the demand was limited, most domestic Chinese companies have turned to North American, Australian and Southeast Asian markets with a large number of Chinese Americans and a large demand for Chinese medicine. There is no special effort in this regard. Registered in EU countries, they are not familiar with legal requirements.
Difficult to flush off, Chinese medicine companies are to enter or retreat? Foci Pharmaceuticals, Qixing Pharmaceuticals, Beijing Tong Ren Tang and other companies are still working hard. Yuan Kelun stated that Qixing Pharmaceutical's certification registration “has completed one-third of the progress of the project and is expected to be completed by the end of 2012.”
But most companies are watching, and some companies directly choose to give up. A number of Sichuan enterprises with qualifications for the import and export of Chinese medicines and Chinese Herbal Pieces stated that they are “less interested” in EU registration. Some enterprises in Zhejiang have chosen to “curve into the army”—“Using the China-ASEAN free trade zone, this enterprise can advance into the EU market through ASEAN.”
Inexhaustible exploration
Abandoning the EU market, what does it mean for Chinese medicine companies?
In the export history of Buddha Ci from 1931, European market share was always small. However, Sun Yu believes that EU registration is a long-term investment and cannot be considered as a temporary gain or loss. “The traditional drug law promulgated by the European Union will give Chinese medicine as a 'pharmaceutical' in theory and legally, and will relatively unify the different management methods for botanical drugs in EU countries, which will help the development of proprietary Chinese medicines in the European market, and will help Chinese patent medicines. It is possible to enter the main traditional plant medicine market in Europe that has not yet been legally sold into Chinese medicines such as Germany, France, Italy, and Poland.
"Chinese medicine is China's most independently-owned intellectual property product, and China has considerable scientific research and industrial foundation. After joining the WTO, Chinese medicine is entirely likely to become a key commodity for China's foreign trade export." Yu Ming, President of the China Pharmaceutical Enterprise Management Association Germany believes that if Chinese patent medicine companies can register under the EU's traditional drug law, they will open up a whole new market for Chinese medicine. At the same time, it will also increase the awareness of the general public in Europe for Chinese medicine, promote the development of other areas of Chinese medicine, and form a virtuous circle.
"Actually, the EU market is not monolithic." Sun Yu told reporters that the EU has its own medication habits, European herbs are mostly prescriptions of 1 to 2 flavors, which is very similar to the traditional Chinese medicines that are frequently used to 7 and 8 flavors. Big difference. Lanzhou Foci also walked the detour when registering in the European Union. In 2006, he tried to register compound Chinese proprietary Chinese medicines in the United Kingdom. The result was more difficult and had no merit. Later, Foci chose the “Enriched Angelica Pill” which was rich in Gansu's authentic Chinese angelica. It once again blew the door to the European Union in 2009. Foci's choice comes from its confidence in the quality of the product. “The EU standard is very strict,” said Sun Yu. The concentrated Angelica Pill has a good reputation in the domestic market. At the same time, overseas sales have not recorded any product complaints.
As for the choice of registration place, there is also great learning. For the second time, Foci chose Sweden. “The strength and scientific technology of the Nordic economy are the most developed. The people’s awareness of traditional medicine, especially Chinese medicine, is relatively high, and the government’s competent authorities are more rigorous about the supervision of traditional medicine.” Foci also selected an experienced partner, Sweden Viccon Co., Ltd., which successfully assisted the Chinese brand “Hua Xi” acupuncture needle products in Swedish and EU countries.
According to industry experts, the EU still allows sales and use of traditional Chinese medicines imported before April 1 this year. According to the expiration date of Chinese patent medicines for three years, Chinese medicines will not be discontinued in the EU market for the time being. However, registration of commonly used proprietary Chinese medicines in accordance with the EU's traditional drug law will be the only way for Chinese medicine to open up the market for European herbal medicine and enter the track of healthy development. Sun Yu said that registration with the European Union will be a long-term and arduous task, requiring the entire industry to work together to find industrial opportunities. "We must have a better understanding of the culture and laws of EU countries. Otherwise, we cannot succeed." Tongrentang-related staff also stated that some of TRT's proprietary Chinese medicines will meet the "15-year sales history in the EU" registration requirements in 2011. The registration work can be carried out and it is hoped that the government department will take the lead to coordinate the negotiation between the Chinese medicine companies and the EU.
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EU plant drug regulatory process
It is well known that European botanicals have been used for more than 700 years, but the level of understanding and management of botanicals in EU countries is not the same.
A drug consisting of a plant or plant dried, crushed or made in any other way, or a drug consisting of one or two or more than two of the above, or a mixture of water or other substances. For natural medicine. In Portugal, in principle, herbal preparations are not included in the scope of medicines and they are included in health products.
In order to promote the standardization of the classification, manufacture and management of herbal medicines, the European Union established the European Organization for Phytotherapeutic Scientific Cooperation (ESCOP) in 1989, embarked on a systematic documentary record, and the legislative basis of member states. In the mid-1990s, the European Commission commissioned the European Association of Self Medicine Industry (AESGP) to carry out extensive investigations on the European herbal market "Herbal medicinal products in the European Union". The intention is also to promote the establishment of the herbal market system.
On December 20, 1995, the Council of Ministers informed the European Commission of the inspection of the herbal products in the European Community at that time. Its purpose is to protect the health of the public, to facilitate industrial development and to facilitate the free trade of pharmaceuticals within the European Community. On April 16, 1996, the European Parliament requested the European Commission to improve the market for herbal medicines and homeopathic medicines, and to organize the establishment of specialized agencies for the approval of traditional medicines. Its purpose is to maintain public safety and free trade of herbs in the EU. On April 23, 1996, the Council of Ministers proposed to the European Commission: Understand the situation of non-prescription herbal medicines in each member country.
In early 1997, the European Medicines Review and Adjudication Administration established the Ad Hoc Herbal Drugs Working Group (referred to as Ad Hoc HMPWG). The working group started to clean up herbal medicines on January 1, 1998 to increase herbal medicines. The standardization efforts and research work to strengthen herbal medicine. In 2001, the European Commission proposed the establishment of an herbal medicine committee in the European Drug Review Authority, which was established after the issuance of the 2004/24/EC in 2004 and is responsible for approving the distribution of herbal medicine sales permits in the European market.
