Chinese medicine companies do not have extraction capacity to close in 2016

2013-11-29 source: the strict management of traditional Chinese medicine extract and natural medicine is about to start in the economic reference report The State Food and drug administration has issued a draft for comments on the notice on strengthening the supervision and administration of extraction and extraction of traditional Chinese medicine, which is strictly regulated The state will vigorously rectify the draft for comments on the extraction industry of traditional Chinese medicine, which states that, from January 1, 2016, all manufacturers of proprietary Chinese medicine that do not have the ability to extract traditional Chinese medicine will stop the production of corresponding varieties, and the approved entrusted processing will also be abolished After the expiration of the period of validity of the Chinese herbal extracts which have obtained the drug approval number, the provincial food and drug administration shall not re register them Industry insiders pointed out that the document shows that the country vigorously rectifies the traditional Chinese medicine extraction industry, the raw materials can ensure the quality, lay the foundation for the subsequent improvement of the overall strength of China's medicine, and also conducive to the realization of the internationalization process of traditional Chinese medicine Under the influence of this policy, the traditional Chinese medicine extraction industry will probably usher in a large-scale merger "The purpose of the document is to make use of the guidance of the regulatory authorities, improve the early communication mechanism, strengthen the supervision of drug research process and drug clinical trial institutions, create a good environment for innovative research and development, and curb low-level duplication." One industry source pointed out The idea of "strict examination and approval, strengthening supervision" is fully implemented in the draft, which includes three aspects First, from January 1, 2016, all Chinese patent medicine manufacturers without the ability to extract traditional Chinese medicine shall stop the production of corresponding varieties, and the approved entrusted processing shall also be abolished Second, the provincial food and Drug Administration will not re register the Chinese herbal extracts that have obtained the drug approval number after the expiry of the approval number The third is to implement the record management for the Chinese patent medicine national drug standard prescription items downloading and the Chinese herbal extracts with separate national drug standards Since January 1, 2015, all extracts of traditional Chinese medicine not filed as required shall not be used in the production of proprietary Chinese medicine The traditional Chinese medicine extract of Yulong hybrid in the Chinese medicine extraction industry is the prescription item of the national drug standard of Chinese patent medicine, and has the volatile oil, oil, extract, flow extract, dry extract, effective component, effective part and other components of the independent national drug standard The extraction of traditional Chinese medicine is a key link in the production and quality management of Chinese patent medicine The production enterprise must have the extraction ability suitable for its production variety and scale According to Guo Fanli, manager of the industry research department of CIC, there are three uses of Chinese herbal extracts in China The first is to make traditional Chinese medicine, and the current products of traditional Chinese medicine are mostly made of raw materials or primary extracts; the second is in the field of health food, the domestic health food has long continued the mode of traditional Chinese medicine, with low requirements for ingredients or markers; the third is functional food and daily cosmetics "At present, the extraction industry of traditional Chinese medicine in China is not as standardized as that in Europe, America, Japan and South Korea The industry is characterized by a mixture of fish and dragons, a lack of strict and comprehensive supervision, and a disorder." Guo told reporters According to the data from the State Food and drug administration, at present, there are more than 160000 domestic drug approval numbers, and more than 60000 traditional Chinese medicine natural drugs "This basically matches the market share of traditional Chinese medicine natural drugs accounting for 1/3 of the pharmaceutical market." An insider pointed out that after clearing up the irrational declaration left over by history, since 2008, an average of 20-30 new Chinese medicine drugs have been approved for market every year, "this number is not small, the key problem is that there are many problems in the overall application for approval of Chinese medicine." It is reported that this is mainly reflected in: the advantages and characteristics of traditional Chinese medicine have not been fully reflected, such as the lack of in-depth and accurate understanding of the advantages and characteristics of traditional Chinese medicine, the lack of scientific data to support the effectiveness and safety of drugs, etc., which makes the foundation of the problem inadequate, the lack of clinical basis of the formula, the inadequate screening of effective parts and components, the basic research and clinical efficacy research exist in the application for approval Problems such as lack of research At the same time, enterprises do not pay enough attention to the new indications of traditional Chinese medicine, new research results and other innovative fields, "secondary scientific research" is not highly motivated, and they do not pay enough attention to the impact of the origin of traditional Chinese medicine on the quality and the sustainable use of resources The new policy is conducive to the export of traditional Chinese medicine A personage in the industry pointed out that traditional Chinese medicine extract is the mainstream of traditional Chinese medicine export At present, relevant departments are in the process of revising the 2015 edition of Chinese Pharmacopoeia Following the 27 new pharmacopoeia in 2010 edition, the 2015 edition of Chinese Pharmacopoeia plans to add 60 new varieties of traditional Chinese Medicine extract Plant extract is the most likely sub industry to realize internationalization in the field of traditional Chinese medicine The new policy will promote the quality of products and accelerate the process of internationalization of traditional Chinese medicine Plant extract industry is a "sunrise industry", accounting for nearly half of the export of traditional Chinese medicine products In 2010, the export value of plant extracts reached 820 million US dollars, and in 2011, the export value exceeded 1 billion US dollars In 2012, the growth of foreign trade of plant extracts slowed down, with the export volume of US $1.16 billion In the first quarter of 2013, China's import and export volume of plant extracts reached 410 million US dollars, an increase of 12.1% year-on-year, of which the export volume was 330 million US dollars, an increase of 11.2% year-on-year, accounting for 47% of the export volume of traditional Chinese medicine products Raising the standard also means another "life and death" war According to the reporter of economic reference, at present, the listed companies engaged in Chinese herbal extracts in China include Kangenbei, Tianshili, Jianfeng group, ANGLI Jiaotong University, Rhine biology, etc Kangenbei is the first company to develop ginkgo biloba preparation in China ANGLI subsidiary of Jiaotong University is the largest plant extract enterprise in China Its main products include Siraitia grosvenorii extract, artemisinin, etc Rhine biological leading products include rhodiola extract, Siraitia grosvenorii extract and so on It is one of the enterprises with the ability to produce the most complete varieties of plant extracts in China "In order to ensure the production of the large enterprises that used to fake the extraction process of traditional Chinese medicine, they must expand new extraction workshops or directly purchase small enterprises that do not meet the policy but meet the quality standards." Guo Fanli pointed out that the new policy actually requires Chinese medicine enterprises to be responsible for the final products produced, strengthen the construction of product quality management system, and the company should manage everything from the extraction and production of raw materials to the manufacture of drugs "It's not easy for small companies to do all this."