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The storm of checking the storm in the pharmaceutical industry is coming 80%of Chinese medicine companies will die
Release time: 2016-08-15 & nbsp & nbsp & nbsp Source: Anonymous
  Combining Boxing of the State Food and Drug Administration recently,Very strong! While rectifying the circulation industry,August 11,The State Food and Drug Administration issued the "Announcement on Carrying out the check of the drug production process (draft for comments)",Add a draft for the consultation of the production process verification,30 days of corporate inspection filing,Flight inspection began in November。
 
  From the national regulatory ideas,There is no problem with this supervision。But for the production of Chinese medicine,Shengjie hard -set GMP cannot be achieved,If it is fully executed,80%of companies will die,Even evolved into a vigorous movement of the exempting Chinese stake online sports bettingstake online sports bettingmedicine preparation enterprise ...
 
  The extraction of medicinal materials cannot be exactly the same as the same actual situation,Should the country be managed by quality or process standards?
 
  I guess myself,The regulatory department issued this production process to verify,It also has its own industry background。For example, Ejiao,According to national quality standards,Marp、Pig Skin、Muzi skin, etc.,Testing is qualified,Only by process standards can we know what raw materials are produced。Historically appearing & ldquo; apple leather & rdquo; event,It is the empty of craft standard,According to the finished product test, it is a qualified product。
 
  So say,This management idea is fine,But the GMP of the foreigner of the foreigner is not realistic。
 
  Maybe this may come,At least 80%of Chinese medicines will become real & ldquo; fake medicine & rdquo;,Because it is produced according to process standards,It is basically impossible to produce a complete standard for patent medicine。Because,Even according to the management of GAP planting medicinal materials,The problem of traditional Chinese medicine is still not solved。
 
  Professor Qiao Shanyi of the Academy of Military Sciences said: I am in the book that is about to be fixed for 20 years & rdquo;,The existence of a chapter I participated in the presence and suggestions of this question。From the perspective of material composition or composition,A medicinal material,Its quality must be a macro and relatively uniform and absolutely uneven。Unable to characterize My stake betting appstake sports betting appall quality features with one or more indicator components。So,Multiple medicinal materials that will definitely change within a certain range of ingredients,It is impossible to use a completely fixed process to produce products with the same quality。
 
  That is to say,The extraction content of each batch of medicinal materials is different,Climate change cannot guarantee the same,Strictly produced in accordance with the process,It cannot solve the problem of the consistent quality of the final pharmaceutical product。
 
   Modification of production technology, is it feasible?
 
  In the draft of comments,Recommended changes in the production process,Allow enterprises to report to modify,This is the great progress of the regulatory department。Of course,It must provide a basis when applying,It must be re -made of quality and stability to have a basis。
 
  But the contradiction is,This seems to mean,Must be acknowledged that the enterprise has always been filled in a fake record? The problem for the extraction and extraction is the authentic medicinal material that the medicinal materials are not purchased?,I dare not say anything! because,It is the quality accident handled by another case。
 
  Also,As mentioned above,How to ensure the consistent quality of Chinese medicinal materials,This is a problem that cannot be solved even after the production process is modified。
 
  Is it necessary to build a production base for self -building?
 
  When chatting with the regulatory authorities,When talking about the above problems,Leadership will talk about the problem stake sports betting appof GAP of the manufacturer。My stake betting appI know I can't talk about it again,Each enterprise builds a Chinese medicinal material planting base is unrealistic at all,The medicinal materials required for traditional Chinese medicine ingredients are all over the country,If the requirements of the authentic medicinal materials,How many planting bases do companies need to build? But the self -built production base is not a day's work, Can Chinese medicine companies only stop production in the short term?
 
  Chinese adults this time if strictly implement the production process verification standard production,Due to unstable content,The quality of the product is finished,The effect of traditional Chinese medicine will be questioned and criticized by the clinical application of western medicine。
 
  The era of large shuffle is here!
 
  Can be approved in history,Approval of more than 10,000 new drugs in one year,It's time to pay off the debt。
 
  Zheng Xiaogu Times gave the opportunity to explode the growth of pharmaceutical companies,Leading China's pharmaceutical industry has grown to more than 6,000 manufacturers,& ldquo;、chaos、Digesty & rdquo; Visible everywhere。Some companies have an exclusive product,It can quickly grow into an enviable enterprise through high -haired space。
 
  This time is the rhythm that solves the problem at one time,Only 30 days of consultation time。So,Strictly speaking,This is a process of re -industry shuffling,God medicine and god sticks will be beaten back to the original,This is a major good for pharmaceutical companies!
 
  Adopt regulatory policies for the National Bureau,We actively agree with,My stake betting appstake sports betting appbut,But I also hope,Chinese medicine as a national strategy,It should still do a good job of top -level design,Let the company develop in the right direction,This is a big problem involving the future of the Chinese medicine industry。