Chinese imitation medicine quality is different，There is a huge gap between Europe and the United States and even India，The General Administration of Food and Drug Administration is determined to regain & ldquo; clean & rdquo;，It is foreseeable，to the end of 2018，China will have a large number of familiar drugs disappearing，At the same time，Pharmaceutical companies will also enter the elimination reorganization。

 

  A copy of & ldquo; Opinions & rdquo; landing，It has caused rare big shocks in the pharmaceutical industry。

 

  Recently，The State Food and Drug Administration (CFDA) issued the "Opinions of the General Office of the State Council on the Evaluation of the Consistency of the Quality and Consistency of Photics"，Everyone approved the listing and included in & ldquo; National Basic Medicine Catalog & RDQUO;。

 

  Consistency，That is, the generic drug must be managed with the original medicine、Intermediate process、Quality and other aspects are consistent，Otherwise，Patients are difficult to guarantee for the safety of medication。

 

  Due to lack of innovation，More than 95%of Chinese chemical medicines are generic drugs，Extract of quality，Few export to overseas。而India, which is also a major imitation drug country，Its product is about 80%exported to Europe and the United States，The gap between the two can be seen。

 

  "Opinions" circles 289 generic drug varieties，involved more than 20,000 drugs，Almost all pharmaceutical manufacturers have products to make consistency evaluation，huge expenditure inevitable。General estimates in the industry，One evaluation of about 4 million-5 million yuan。

 

  In addition，Take the final term at the end of 2018，Time is very tight，According to industry insiders, reporters from the 21st Century Business Herald，From the application reference reagent，Second development of the prescription process，to BE filing and BE test，Then to the final review approval，It takes at least 22 months。

 

  & ldquo; This is just the time to complete the acceptance，instead of the last review time，and I pass it normally，excluding evaluation failure、Time to re -review。& rdquo; The above person said。

 

  stake online sports bettingSo，Stake Sports BettingThe reasonable prediction issued by the "Opinions" is，until the end of 2018，The Chinese market will disappear a lot of medicines that were once familiar with，Some pharmaceutical companies with poor strength will also be eliminated。

 

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  Due to high cost and urgent time，Pharmaceutical companies generally fall into anxiety。

 

  Representative of the National People's Congress、Ren Wuxian, chairman of Yabao Pharmaceutical Industry Ren Wuxian, said in an interview with the 21st Century Business Herald，Current consistency evaluation A variety of 3 million yuan is friendship price，5 million yuan is a market price。

 

  There is an industry in the industry carefully analyzed the consistency evaluation.，Structural confirmation and verification of 100,000 yuan (crystal type、impurities、particle size)，Process verification、Dynamic production、Small Chinese trial production of 100,000 yuan，Registration and inspection fee 250,000 yuan，Human cost 1 million yuan，BE test 2.5 million yuan。

 

  If a pharmaceutical company has 100 kinds of medicines for consistency evaluation，Then you need to pay 500 million yuan for this。

 

  According to insight data，The company with the most consistent evaluation varieties in the first batch of consistency evaluations is Shanghai Medical Group、China Resources Shuanghe Pharmaceutical、Guang Pharmaceutical Baiyunshan Pharmaceutical Group、Harbin Pharmaceutical Group Co., Ltd.、Shanghai Fosun Medicine，The number of approval numbers is 505、211、200、144、132。​​If 26,700 varieties do consistent evaluations，It is expected to spend 100 billion yuan。

 

  What is more likely to make the pharmaceutical company is not just a problem of money，Due to consistency evaluation test resources, the laboratory、The scarcity of the hospital，I often can't find the embarrassment of the laboratory。

 

  In the consistency evaluation ecological chain, pharmaceutical companies、Pharmaceutical Institution、Clinical CRO、be base、Biological sample detection、Data statistics and other 7 parties，Holdings。Where，BE experiment This link allows many companies & ldquo; headache & rdquo;。

 

  After the self -examination of the drug clinical experiment on July 22 last year，Hospitals with BE qualifications undertake the enthusiasm of clinical experiments is not high，Since the hospital undertakes clinical experiments, it earns bed management fees，But many hospital beds are in short supply，The hospital is unwilling to increase clinical experimental beds。

 

  According to statistics，At present, there are 53 institutions with BE qualifications，Average about 20 beds，The amount of BE that can be undertaken a year is about 30，Calculated with this，It can not exceed 2,000 varieties through verification every year，There are only 6,000 varieties that can be completed in three years。and the 2012 version of "National Basic Drug Catalog" involved about 300 consistency evaluation varieties，More than 26,700 approval number。

 

  My stake betting appMy stake betting app& ldquo; shortage of clinical experiment institutions，BE institutions also start to pick projects，I even refuse some projects。& rdquo; The chairman of a listed pharmaceutical company said to the 21st Century Business Herald reporter。Another industry media report，Due to resource tension，At present, some pharmaceutical companies have begun to talk about monopoly hospital BE resources，The agreement between the two parties，The hospital only does the BE experiment of this company's family，Squeezing competitors from the text。

 

  Tao Chunlei, general manager of Anhui Wanbang Pharmaceutical Technology Co., Ltd., used the word & ldquo; anxiety & rdquo;。

 

  In the above data check the storm，1,622 varieties of more than 80%withdrawal，Enterprise applicant、CRO、Clinical institutions、The pharmaceutical regulatory department has briefly trapped into a crisis of trust，Domestic BE test is also & ldquo;。Among them, there are many large listed pharmaceutical companies，Even Hengrui Pharmaceutical, which is known for its research and development, has also taken the initiative to withdraw hundreds of millions of investment。

 

  Even if we have money、With BE laboratory，It does not mean that the consistency evaluation can be completed within the specified time。until the end of 2018，A total of 3 months of time，Very nervous。

 

  Consistency Evaluation is divided into two stages of research and declaration，Without considering the interference of various factors，It is expected to use 16-20 months in the research stage，6-8 months in the application stage，Enterprises must rush to complete the consistency evaluation time at the end of 2018。

 

  & ldquo; Time is really nervous，We decided to choose one from three medicines to make consistency evaluations。& rdquo; The person in charge of a pharmaceutical company said in an interview with the 21st Century Business Herald.。It is reported，​​Out of time and cost consideration，The strategy of the corporate response is mostly & ldquo; choice & rdquo;。

 

  Shi Lichen, the person in charge of Beijing Dingchen Medical Management Consultation, said，Pharmaceutical companies must make an optimal choice，Because the time to give the drug company is indeed not much now，And there are various problems such as clinical trial traffic jams。

 

  & ldquo; but，This move can be described as the supply side of the generic drug industry，M & A in the future pharmaceutical industry will accelerate。50%of the drug approval in the future will be eliminated。But this will help companies that grab the track to quickly expand the market。& rdquo;

 

  Affected by this，Calculation of industry insiders，In nearly 20,000 text numbers of 289 evaluation varieties，Considering that there are too many dosage forms that are inconsistent with the original research，About 10,000 text numbers that can be evaluated quickly。

 

  but，Opinions stipulate at the same time，Since the first company variety passes the consistency evaluation，No longer accepts the consistency evaluation application of the same variety of other pharmaceutical manufacturers in three Stake Sports Bettingyears。stake online sports bettingThis means，Pharmaceutical companies that have been evaluated have a three -year monopoly period in some drugs，It is a good information for large companies with strong strength。

 

  eliminating low -end capacity

 

  From the perspective of the industry，This time the CFDA motion of pharmaceutical companies & ldquo; Zhenge & rdquo;，Actually it is also & ldquo; helpless and must & rdquo;。

 

  Chinese imitation medicine quality is different，Affecting patients with medication。Li Zhengqi, Director of the Pharmaceutical Certification Management Center of the State Food and Drug Administration, wrote an article，The overall quality of domestic generic drugs is far from the original research medicine，Some are even safe invalid medicines。

 

  Estimation of Guoxin Securities，The scale of generic drugs is nearly 500 billion yuan，accounted for 95%in the prescription volume。However, a large number of domestic generic drugs are rough and inferior、Safety and invalidity，The industry's gross profit margin is less than 10%，far below the international average of 50%。

 

  It is understood，CFDA once organized a draw check in 2008，Select some domestic generic drugs and original drugs for in vitro dissolution test comparison，Different from the difference between domestic generic drugs and the abolishment behavior of the original research drug，No one can meet the qualified standard。

 

  India, which is also a major imitation drug country，Its drug preparation system and standards are set according to European and American countries，About 80%of generic drug exports to developed countries。But China's generic drugs rarely get recognition from foreign markets。

 

  In addition，China's generic drugs are actually occupied by most of the occupation number，but not produced。

 

  Guoxin Securities quoted relevant data to point out，At present, the Pharmaceutical Supervision Bureau has approved a total of 189,000 generic drug varieties，But the approval number of actual production and sales is only 40,000 to 50,000，2/3 of the drug number is the zombie number & rdquo;。

 

  Actually，Consistency evaluation is not just & ldquo; Chinese characteristics & rdquo;。

 

  Hai'an Bisheng Pharmaceutical CEO Lei Jifeng pointed out to the 21st Century Business Herald，In Europe、The United States、Japan，Pharmaceutical companies have also experienced the consistency evaluation of generic drugs & ldquo;，It is considered & ldquo; great cleaning & rdquo; weapon。

 

  If the 1970s，The United States lasted 10 years，eliminated about 6,000 unqualified drugs; around 1975，Britain evaluated and checked 36,000 medicines; 1997，Started & ldquo; drug quality re -evaluation project & rdquo;，About 730 varieties have been completed so far。After & ldquo; Rehabilitation project & rdquo;，All three countries have achieved upgrading of the generic drug industry，Drug Quality、Industry Ecology、Industrial value has been significantly increased。

 

  General prediction in the industry，China will also take this opportunity，Demonstration of low -end production capacity in the pharmaceutical industry，Accelerate the stake sports betting appmerger and reorganization of the industry。

 

  & ldquo; This will also exacerbate the industry'My stake betting apps stake sports betting appmerger and reorganization to a certain extent。Some small enterprises with weak capital strength if you have a good variety，You can seek support from large enterprises。& rdquo; Shi Lichen said。

 

  In the opinion of Dr. Huang Yi, Sino -German Securities Co., Ltd.，& ldquo; Now my country's pharmaceutical market is a bit of a three -looking place worldwide，But the company's strength is far from the multinational giant。The top ten drug companies in the United States account for about 52.23%of the market share，The top ten of our country's top ten accounts for only 18%。CFDA has approved 99867 chemical medicine number，It is monitored to have only 40816 batch.，accounting for 40.87%，Half -variety highly repeat，The activity is not high。& rdquo;

 

  Some people in the industry use the key variety of high blood pressure，The overall proportion of imitation drugs in the United States is 75%，The overall proportion of the original drug research drugs in my country is 62%。domestic market，10 original research pharmaceutical companies monopolized 94%of the original research pharmaceutical market，These companies include Novartis、Astrikan、Pfizer, etc. A total of 350 companies are selling hypertension imitation drugs，The top 15 companies only cover 55%of the market share，These companies include Shi Huida、Zhengda Tianqing、Yangzijiang、Stone Medicine Group。

 

  Xu Dongji, chief expert of Renmin University of China Medical and Health Industry Development Research Center, analyzes，China's pharmaceutical industry has entered the aging phase since 2013，If the industry wants to develop，It must face social capital influx and structural adjustment、Adjustment of industrial form、Major adjustment of industrial supply -side structure。