CFDA rectifies the disorder of extracts, and non pharmaceutical enterprises are forbidden to cross the border

How many pharmaceutical companies are using Chinese herbal extracts produced by non pharmaceutical companies? What is the annual output of Chinese herbal extracts produced by non pharmaceutical enterprises? Is the traditional Chinese medicine extract circulated in the market processed before production and feeding? How many of the dregs of traditional Chinese medicine extracts that should have been treated have illegally flowed to the patients? For the traditional Chinese medicine industry, these are all "sensitive" topics But now, the topic of "desensitization" work has begun At present, the "notice on strengthening the supervision and management of the extraction and extraction of traditional Chinese medicine" (hereinafter referred to as the "notice") which is seeking opinions in the industry will undoubtedly pry the nerve of the Chinese medicine industry According to the proposed new policy, non pharmaceutical enterprises will not be allowed to engage in the production business of Chinese herbal extracts in the future, so as to cope with the closing of the door of entrusted processing of Chinese herbal extracts In order to further understand the current situation of traditional Chinese medicine extraction and comprehensively evaluate the industry's suggestions on the notice, the State Food and Drug Administration recently commissioned the association to send a questionnaire to the industry, the reporter from the Chinese Traditional Medicine Association (CMCA) learned yesterday According to some member enterprises of the association, once the new policy stipulated in the notice is implemented, it will be inevitable for the traditional Chinese medicine extraction and patent medicine manufacturing industry to speed up the reshuffle On January 1, 2016, the deadline will come to "now the entrusted processing of traditional Chinese medicine extracts is very common, and it is indeed the time for governance." Jiang Erguo, deputy director of the information center of traditional Chinese medicine of the China Association of traditional Chinese medicine and the network of traditional Chinese medicine heaven and earth, said in an interview with reporters from Nandu Jiang did not provide relevant data on Chinese herbal extracts Since most of the Chinese herbal extracts are produced by non pharmaceutical enterprises, there is no statistical data in this regard in the Chinese herbal medicine information center of the Chinese Herbal Medicine Association However, in Jiang's view, the notice intends to prohibit the entrusted processing of Chinese medicine extraction, which will make Chinese medicine more transparent in the feeding process The notice, which is seeking opinions, shows that all localities plan to stop the examination and approval of the entrusted processing of traditional Chinese medicine extraction in the future The previously approved entrusted processing should be strengthened in strict accordance with the requirements of the notice on strengthening the supervision and management of pre-treatment and extraction of traditional Chinese Medicine issued by the former State Drug Administration (SFDA [2002] No 84) In addition, from January 1, 2016, all Chinese patent medicine manufacturers without the ability to extract traditional Chinese medicine will stop the production of corresponding varieties, and the approved entrusted processing will be abolished According to the notice, the traditional Chinese medicine extracts with separate national drug standards will adopt the filing management system in the future 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 As the Chinese patent medicine manufacturers are required to strictly follow the drug standard for feeding production, only when the Chinese herbal extract is prescribed under the prescription, can they purchase and use the registered Chinese herbal extract In the view of the industry, if the notice is officially promulgated, the practice of Chinese patent medicine enterprises using Chinese herbal extracts at will will will also be expected to be curbed According to the latest news from the China Association of traditional Chinese medicine, which blocked the "dregs" return channel, the association has been entrusted by the Department of pharmaceutical supervision of the State Food and drug administration to solicit opinions from the member enterprises of the association According to the electronic questionnaire obtained by Nandu reporter, in addition to providing the real data of the area and output of the free production workshop of traditional Chinese medicine extracts, the table also needs to report the annual output of the entrusted production independently, and whether the self built extraction workshop can be completed before January 1, 2016 In the option of traditional Chinese medicine extract, enterprises are required to report the acquisition methods of traditional Chinese medicine extract, including self production, public production and outsourcing In addition, whether there is internal control quality standard and whether there is fixed industry of traditional Chinese medicine source is also within the range of adjustment In addition, for the treatment of Chinese herbal medicine before and after the extraction of waste residues, it is intended to seek opinions and report the actual situation The pretreatment of traditional Chinese medicine is processing, which has the function of supervising and increasing efficiency As for the treatment of waste drug residues, it is only after problems have been found in the circulation and terminal consumption links that they are included in the policy revision According to an expert in traditional Chinese medicine in Guangdong Province, some people have taken the prescriptions they prescribe The reason why they are not as effective as before is that there is something wrong with the effective ingredients in the herbs According to its introduction, in addition to the decline in the content of effective ingredients caused by artificial planting and other factors, a more serious problem is that some medicinal materials that have been extracted with effective ingredients have returned to the hospital and drugstore terminals in various ways "This problem does exist We have found that the dregs of the effective ingredients that have been extracted are mixed in the raw materials " An expert close to the Chinese Herbal Medicine Association also pointed out to the Nandu reporter The cost is rising and the ship is speeding up the industry's reshuffle This is the view of Zhang Shichen, director of the professional committee of Chinese herbal pieces of the Chinese Herbal Medicine Association The professional committee is very supportive of the upcoming work of strengthening the supervision and management of the extraction and extraction of traditional Chinese medicine However, in the view of a pharmaceutical company in Guangzhou Development Zone, the closing of the door of entrusted processing of Chinese medicine extraction will increase the cost of the industry According to the notice, each provincial food and drug administration shall, after the issuance of the notice, inspect the Chinese herbal extract production enterprises that have put forward the record according to the GMP and the national drug standards of the Chinese herbal extract If the requirements are met, the drug production license shall be issued and the name of the permitted Chinese herbal extract shall be indicated In the view of professionals, this is actually to manage the traditional Chinese medicine extraction company as a pharmaceutical enterprise For many traditional Chinese medicine extraction companies that were previously produced by food or chemical standards organizations, the GMP certification will face a large transformation cost And this cost is expected to eventually be transmitted to Chinese patent medicine enterprises In addition, because the notice also plans to issue the requirements of "Chinese herbal extracts with manufacturing methods attached to the Chinese patent medicine standard and without separate national standards, the relevant Chinese patent medicine manufacturers must extract by themselves and cannot purchase", which means that these pharmaceutical enterprises must build their own extraction workshop before the big limit specified in the notice in 2016, and the investment in this part of plant and equipment will also be considerable Number Experts from the China Medical Insurance chamber of Commerce yesterday accepted a call from the Nandu reporter that issues arising from the circular, including the extraction of local traditional Chinese medicine and the import and export of extracts, need to be properly addressed Market analysts pointed out that the "notice" will be a big negative for small and medium-sized enterprises in the industry chain of traditional Chinese medicine extraction and patent medicine manufacturing, while for the leading enterprises of traditional Chinese medicine that have built their own extraction business, the industry shuffle will also be accelerated.