The quality standard of plant extracts is clear or represents the first entry of traditional Chinese medicine into the EU

Business club, May 10 - the 7-year transition period of EU's "traditional botanical medicine registration procedure directive" ended on April 30 As China's proprietary Chinese medicine has not been successfully registered so far, it is almost certain to withdraw from the EU market However, as a large market of botanical drugs, the failure of Chinese patent medicine may create an opportunity for plant extracts In the face of EU "traditional botanical medicine registration procedure directive", the main affected is Chinese patent medicine in China Because most domestic Chinese medicine enterprises are difficult to complete the registration in the form of drugs in a short time, and because the quality standard of plant extract is relatively clear, it is easier to enter the EU botanical medicine market than Chinese patent medicine Therefore, plant extracts may be the representative of traditional Chinese medicine and enter the EU drug market first, which can also be regarded as the circuitous tactics of "going out" of Chinese traditional medicine products Plant extracts in the EU market have some profound and complex theories of traditional Chinese medicine and the limitations of research level, which are far from the requirements of the west, and have become the bottleneck of the export of Chinese patent medicine At present, China's export of Chinese patent medicine can only be used as food / food supplement Although 2004 / 24 / EC Directive is an important opportunity for China's use of Chinese patent medicine as a drug, so far, no domestic enterprise has simplified registration through the EU traditional medicine In the long run, it will take a lot of efforts to enter the European herbal medicine market in the form of Chinese patent medicine Plant extract is a kind of product which uses modern technology to process Chinese herbal medicine and other plants It has high added value It can not only be used directly, but also be used as raw materials of various herbal preparations and food supplements Plant extract is the closest product form to the Western plant medicine consciousness It is generally not guided by the theory of traditional Chinese medicine The product quality standard is relatively clear and easy to be understood and accepted by Westerners It has a clear legal position, a large market capacity and a stable and smooth market channel in Europe Therefore, plant extracts may take the lead in entering the EU drug market as a representative of traditional Chinese medicine However, it is still the ultimate goal for Chinese patent medicine to enter the EU market as a drug and promote the internationalization of traditional Chinese medicine At present, China's plant extract products mainly enter the EU market with food or food supplements or plant medicine raw materials Among them, the medicinal plant extracts shall comply with the relevant provisions of EU human drug registration Directive 2001 / 83 / EC and EU traditional plant drug registration procedure Directive 2004 / 24 / EC Meanwhile, the products that enter the EU market as raw materials of plant drugs shall also be provided with CEP Certificate (COS certification) or edmf documents According to the statistics of EU EDQM, there are few enterprises that conduct cos certification for global plant products As the cos certification is for the products recorded in the European Pharmacopoeia, there are few domestic enterprises involved At present, the medicinal extract products exported from China are generally crude ones, which need to be further refined by European enterprises before use The defect behind the rapid development is the main force of the import and export of traditional Chinese medicine In 2010, the export of plant extracts in China increased to US $801.5 billion, a year-on-year increase of 17.62%, accounting for 41.92% of the total export of traditional Chinese medicine With the rapid growth of plant extract industry in China, the number and scale of plant extract enterprises have also been improved to a certain extent, but there are still worries behind the rapid development, especially the lack of core competitiveness At present, there are hundreds of plant extracts produced in China, among which the large-scale production and products for export are mainly Ginkgo biloba extract (accounting for 70% of the international market), green tea extract (accounting for 75% of the international market), ginseng extract, licorice extract, ephedra extract, etc These products have stable market and good market in western countries But China's extractive enterprises are generally young, and nearly 70% of them entered the industry after 2001 The scale of these enterprises is small, the average sales volume of extract products is 1.5 million US dollars, lacking market development and technology R & D strength; meanwhile, the varieties and specifications are the same, mainly relying on low cost and low price to participate in international competition, and lacking competitive international brands According to the guidance on the export of plant extracts issued by China Chamber of Commerce for the import and export of medical and health products in December last year, from the perspective of quantity and scale, China's extract export enterprises have made great progress in 2002-2009, but from the change of market share of enterprise export amount, the market share of private enterprises has increased greatly (from 14.1% in 2002 to 43.1% in 2009 %); the market share of foreign-funded enterprises increased steadily (from 29.4% in 2002 to 41.3% in 2009); while the market share of state-owned enterprises decreased significantly (from 56.5% in 2002 to 15.4% in 2009) By combining the number distribution of enterprises with the market share, the market share of private enterprises accounting for 68.3% is only 43.1%, while the market share of foreign-funded enterprises accounting for 13.4% is 41.3% It is not difficult to see that the scale of Chinese plant extract enterprises is still generally small, and the participation of foreign capital is relatively high In addition, from 2002 to 2009, the export volume of the top 8 enterprises ranked in China's export volume of extract products increased from 22.2% to 33.8%, but less than 40% According to the division standard of industrial concentration of American economist Bain and Japan's general industry province, it belongs to the low concentration competition type, indicating that the concentration level of China's export industry of extract is still relatively low The level of international competitiveness needs to be further improved Improving the international competitiveness is the key China's plant extract industry is the most likely sub industry to achieve internationalization in the field of traditional Chinese medicine However, due to the disunity of standards and the lack of corresponding market supervision departments, it is difficult to form industry self-discipline and industrial concentration, resulting in many enterprises still staying in the scope of chemical enterprises, and the overall scale of enterprises is small, and the international competitiveness is not strong After the international financial crisis, the three major markets of Europe, the United States and Japan have shown a strong trend of localization, which put forward new requirements for the price, cost and safety of extract products Industry insiders pointed out that at present, Chinese enterprises are facing three challenges in the international market: first, the localization trend of each market Unsaturated fatty acid products are highly valued in European market, mainly produced in Nordic countries such as Norway; fermentation and legume products have become mainstream products in Japanese market, but few in China; the top seven products sold in American market are all localized products, which tends to weaken Chinese products Second, the innovation speed of global extract products is slow, and the price and cost become the focus of competition The days when Chinese enterprises used to rely on large European and American companies to launch star products every year to drive the market are gone forever Third, Chinese extract products are becoming the synonym of "big goods" and "cheap goods" Once they are "well-known", the market competitiveness will be difficult to guarantee and the future development will be worrying In this case, China's plant extract enterprises must improve their competitiveness as soon as possible, and plan and improve their products, standards, quality control, innovation ability, enterprise development strategies and other aspects to promote the healthy development of China's extract industry The first is to establish a unified international standard and actively promote the existing industry standards At the same time, with reference to the international standards, advanced inspection and testing technologies and methods are used to establish a perfect and standardized industry standard system for more plant species More importantly, the upgrading of industry standards to national standards should be gradually promoted At the same time, we should properly raise the industry access threshold, standardize the access mechanism of the extractive industry, strengthen the qualification examination of production enterprises, encourage the merger and reorganization of enterprises, and promote the adjustment of industry structure Secondly, efforts should be made to improve product quality and international competitiveness The production and R & D of plant extracts should learn from the advanced experience of GMP, GSP, GLP, GCP, gap, etc., and explore the establishment of GEP (quality management standards for extract production) In terms of product quality control, we can refer to some quality systems or quality requirements formulated by European and American countries Through improving the backward production process, adopting advanced extraction, separation, purification and drying equipment and technology, further improving the quality standards of plant extracts, and constantly improving the scientific and technological content of products At the same time, we should strengthen the control of product safety index, especially the control of heavy metal content, pesticide residue and organic solvent residue The third is to attach importance to market research and innovate product marketing mode For foreign markets, enterprises should pay close attention to market dynamics, understand market access requirements, and formulate product entry strategies according to the specific conditions of the target market In addition, the enterprise should also innovate the marketing mode of products, such as strengthening project cooperation with large international companies, and paying attention to the development and cultivation of domestic market As the extract market is also affected by upstream and downstream industries, the extract enterprises should first ensure the supply of raw materials It is suggested that the extract enterprises should expand the market to the downstream industry chain, ensure and promote the production and sales of the extract products through the deep processing of the extract products, and pay attention to the development of new resource-based extract products such as Lycium barbarum and Rhodiola In addition, the plant lifting enterprises should also strengthen the self-discipline construction of the industry and support the work of the Association; increase investment in product and technology innovation, establish international brands; increase investment in basic research, promote the development of the combination of production, learning and research; pay attention to resource and environmental protection, and achieve sustainable development.