& ldquo; The cold winter of Chinese generic drugs is coming，Conservative estimates that one -third of domestic pharmaceutical factories will face closure in the next few years。& rdquo; A professionals in the pharmaceutical industry told the surging news reporter。

 

  Since the end of March，The State Food and Drug Administration issued three links on the official website with notifications related to the assessment of the consistency of generic drugs，Opinions of the General Office of the State Council on the evaluation of the consistency evaluation of the quality and efficacy of generic drugs and work procedures for public solicitation。

 

  The so -called consistency evaluation，It means that generic drugs need to reach the level consistent with the original research medicine in quality and efficacy。

 

  Carry out the consistency evaluation of generic drugs，This require，It has reached the time when the arrow is on the string。

 

  90%of the drug approval exit the market

 

  According to the Opinions on Implementing the Evaluation of the Evaluation of the quality and efficacy of the quality and efficacy of the "General Office of the State Council (Consultation Draft) issued" & rdquo;)，It is required to approve the listing of listing before October 1, 2007、Chemical Drugs Imitation Drug Oral Solid Order，In principle, consistency evaluation should be completed by the end of 2018。& lt; Opinions of the General Office of the State Council on the evaluation of the consistency evaluation of the quality and efficacy of generic drugs & gt;

 

  Data statistics，China 5,000 pharmaceutical companies，There are 3,000 generic pharmaceutical companies will face the test of the policy。

 

   & ldquo; The reason why the state wants to do this is a problem leftover，You must also do this。& rdquo; Shi Lichen, the founder of Beijing Dingchen Medical Management Consulting Center, said。

 

  2004 & mdash; 2005，The former Director of the State Food and Drug Administration, stake sports betting appstake betting appZheng Xiaoyu, who was in charge of the State Drug Administration，In 2004, the Pharmaceutical Supervision Bureau accepted 1,0009 species & ldquo; new medicine & rdquo; application，At the same time, the U.S. Pharmaceutical Supervision Bureau only accepted 148 kinds。2005，The Pharmaceutical Supervision Bureau approved the drug registration application items 11086 cases，Among them, 80%are imitation medicines。The flood of the Chinese imitation medicine number began at that time。

 

   & ldquo; The biggest sequelae is the financial insurance for medical insurance payment，I can’t afford so many generic drugs。& rdquo; Shi Lichen said。

 

  China's imitation drug market has developed rapidly in the past ten years，Guoxin Securities Estimation，At present, the scale of domestic generic drugs is nearly 500 billion yuan，There are nearly 5,000 pharmaceutical companies，The total number of existing drug approval texts is as high as 189,000，Imitation drugs accounted for 95%in the prescription volume。However, a large number of domestic generic drugs are rough and inferior、Safety and invalid，The industry's gross profit margin is less than 10%，far below the international average 40%& mdash; 50%level。

 

  Shi Lichen estimation，Standards for evaluation according to consistency，At present, medicines obtained in China，No more than half of them meet the requirements。

 

  According to the draft of comments，Among similar medicines，Once the first three passed the consistency evaluation，Subsequent medicines will not enter the list of medical insurance procurement。Can't enter the list of medical insurance procurement basis basically sentenced this drug to the death penalty on the official procurement channel。According to industry estimates，This requirement is strictly implemented，China will have 90%of the drug number to withdraw from the market。

 

  This consistency evaluation is mainly targeted at oral solid preparations in chemicals，Covering 292 base drugs，involved tens of thousands of approvals。But Shi Lichen pointed out，Two -thirds of the current domestic generic drugs are not actual & ldquo; zombie approval & rdquo;。After the policy is implemented，Help this part & ldquo; zombie approval & rdquo;。

 

  huge evaluation and time cost

 

  Zhang Qing, the person in charge of the Drug Registration Office of the Shanghai Food and Drug Administration, told the surging news reporter，Local regulatory authorities only have the responsibilities promoted and promoted during the implementation of the evaluation，No ability to implement compulsory implementation，It is necessary to rely on the text number to hold the enterprise consciously。

 

  & ldquo; This is a completely autonomous behavior，At present，Some companies are already actively act，But there are still many pharmaceutical companies My stake betting appMy stake betting appwatching and seeing。& rdquo; Zhang Qing said。

 

  Dested，At present, many similar drugs in China correspond to hundreds of batches，This kind of medicine strives to pass the evaluation process like Sali gold gold，The winner is just a minority。What kind of company can finally win?

 

  Shi Lichen pointed out，In similar medicines，Those companies that have strong scientific research strength and have accumulated clinical data can only strive for time to grab the opportunity。Shanghai Anbisheng Pharmaceutical CEO、Lei Jifeng, director of Qingdao Baiyang Pharmaceutical, thinks，It must be companies that are at the forefront of the industry。Because this is not only a cruel scientific research ability war，It is also the competition of financial resources。

 

  A researcher at the National Medicine Group revealed to reporters，At present, the consistency evaluation market quotation of a single variety of drugs in China has reached 3 million-6 million，The entire industry may face a huge expenditure of 90 billion yuan。

 

  Great evaluation costs make some small and medium -sized pharmaceutical companies be bitter。The person in charge of a pharmaceutical company directly told reporters & ldquo; This topic is too sensitive & rdquo;。

 

  Dested，For those who have no economic strength，Small pharmaceutical companies with no innovative ability for，As the war has not yet launched，They chose to durate the drum。

 

  However, even the strong big companies are not without pressure。Previous media estimation，Like National Medicine、Drugs, a giant company with a drug approval number of more than 1,500 or more，If all the consistency evaluation is taken again，The amount of funds required will cost as much as 4.5 billion。

 

  Lei Jifeng said，The cost of consistency evaluation mainly comes from biological equivalent experiments。But financial resources are just one aspect of the problem，Time problem is equally difficult。At present, there are only more than 100 professional institutions with national qualifications to do biological equivalent experiments。Once the policy is landing，Enterprise swarming to do experiments will inevitably face the situation of queuing。

 

  Shi Lichen pointed out，At present, the time for each drug consistency evaluation requires 1-2 years，Want to complete the application work of all text numbers in just three years，It is almost impossible task。Calculate according to the number of existing numbers，It takes more than ten years to spend all over it。In the case of a limited number of clinical research institutions，Consistency evaluation work will also squeeze out a large number of innovative drugs for clinical trials。

 

  The person in charge of a large pharmaceutical company who is unknown to name tells reporters，The pharmaceutical number held by the company is stake online sports bettingstake online sports bettingbased on hundreds ofats，Different from the evaluation time and region，Each approval is spent to complete the evaluation of more than 100,000 to hundreds of thousands。& ldquo; It is impossible to take a complete evaluation，There will definitely be a choice，But how to choose the secrets involved in corporate secrets。& rdquo; The person in charge said。

 

  Lei Jifeng said，For pharmaceutical companies，The process of this choice is like & ldquo; Tian Ji horse racing & rdquo;，It is necessary to consider your own situation，It is also necessary to estimate the strength of the opponent。

 

  & ldquo; Some companies will focus on retaining large varieties of drugs，Some will win the market for unique varieties，Some choose those competitive advantages、Application for evaluation of drugs with technical difficulty，There will even be a company who choose to give up the application for the existing number，Choose to invest in new research and development areas。& rdquo; Lei Jifeng said。

 

  For example，Pharmaceutical Group disclosed to Peng Mei News，The Group has launched the consistency evaluation work of generic drugs since 2013，Because there are many varieties，The company puts sales scale、profitability、Elements such as raw materials supporting foundations are incorporated into the indicator of comprehensive evaluation，It will give priority to low -cost medicines with advantages in key varieties and drug bidding、Gynecological、The consistency evaluation of the variety in the field of pediatrics。

 

  Lei Jifeng said，Different strategies adopted by the enterprise，It will also determine the competitive pattern of the future market。Dested，The big shuffle in the pharmaceutical industry has begun since this moment。Future challenges，How does it focus on small enterprises to place resources，Opportunity to get up; for large companies，Then you need to weigh the advantages and disadvantages，Consider how to continue to sit in the mountains and mountains。

 

  & ldquo;

 

  During the interview,，Reporters also learned from many parties，In the future, the generic drugs that pass the consistency evaluation will get a certain advantage in the process of pharmaceutical bidding and government procurement。The person in charge of a pharmaceutical company said，This helps help truly effective generic drugs to increase market share。

 

  It is understood，At present, the state adopts the subsidy form of imported drugs and generic drugs in imports，The reimbursement ratio of the two categories of drugs is not much different，But because the original research drugs are much higher than the generic drug in terms of price，Therefore, the actual reimbursement amount is Stake Sports Bettingfar less than the original research medicine。

 

   stake betting appLei Jifeng thinks，If the reimbursement of generic drugs that pass the consistency evaluation & ldquo; absolute amount & rdquo; increase to the same level as the original research medicine，Is a more affordable approach to the people。At the same time, it is also a support for powerful generic drug companies。

 

   & ldquo; There is a strange phenomenon in China that is not available in other countries，The price of many original drug research drugs will not decrease due to the expiration of the patent，It will not be quickly seized by cheap generic drugs。In our medical insurance reimbursement form，The original research medicines that have expired patents still occupy most of the resources。Why is this? It is because the effectiveness and quality of domestic generic drugs are not available，Can't win the trust of ordinary people。& rdquo; Lei Jifeng said。

 

  Industry insiders pointed out，At present, domestic drug prices present the bipolar differentiation of imported original drugs and domestic generic drugs，Drugs at the middle price are seriously missing，This gap requires those high -quality generic drugs that pass the consistency evaluation to fill it with。