Insufficient R & D investment in Chinese pharmaceutical manufacturers，Innovation ability is not strong，There is a large gap between the quality of some generic drugs and the international advanced level。China has already sounded the horn of the Battle of Drug Self -Rescue，Completely unfolding the consistency evaluation of generic drugs，To reduce this gap。

 

  The "Opinions on the Evaluation of the Consistent Evaluation of the Quality and Effective Effects" issued by the General Office of the State Council (hereinafter referred to as "Opinions") officially announced in March，Requires pharmaceutical companies to evaluate the consistency of My stake betting appStake Sports Bettingthe quality and efficacy of generic drugs and original drugs，The big shuffle in the entire pharmaceutical industry is coming。& ldquo; More than half a year passed，Many companies have not started this job yet。& rdquo; an expert in the pharmaceutical industry said。

 

  The distance between generic drugs and original drugs

 

  FDA (Food and Drug Administration) related documents，The generic drug that can be approved by the FDA must meet the following conditions: the same active ingredients as the imitation products，Among them, the non -active ingredients can be different; the indications of the imitation products、Dosage form、Specification、The consistency of the administration; the effect of biological equivalent; the quality meets the same requirements; the GMP standards produced as the same strictly。

 

   & ldquo; The original research medicine only requires a piece of quantity，Eat 5 tablets in China，Want to reverse this situation，Improve the efficacy of Chinese generic drugs，Only through drug consistency evaluation，and this is a general method internationally，It is also a must -have road。History，The government stake online sports bettingstake online sports bettingprescribed a mouth for generic drugs，I went on the road without doing the experiment of consistency evaluation of medicine，Can't avoid this problem so far。My stake betting appStake Sports Bettingthe quality and efficacy of Chinese medicines must be further improved。& rdquo; an expert who participated in the "National Drug Safety & LDQUO; Twelve Five -Year Plan" said drafted。

 

 In the absence of medicine and medicine、In the case of the basic gap in the pharmaceutical industry，The emergence of generic drugs，I have saved the life of many people。At present, there are 187,000 drug approval number in my country，Among them, 168,000 medicine numbers were approved by 2007。7000 species that have been approved、121,000 chemicals，Most of them are generic drugs。

 

   & ldquo; Compared with the original medicine，Low imitation drugs，Welcome to consumers。but，Chinese drug approval only & lsquo; quality standards & rsquo; control，No biological equivalent verification。That is to say，Most generic drugs are just the same chemical composition，Whether clinical effectiveness is equivalent to not guaranteed，Caused a lot of & lsquo; Qualified invalid drugs & rsquo;。Internationally do not recognize the generic drugs of self -produced self -produced self。& rdquo; an expert in stake betting appA pharmaceutical industry said。

 

  Inspector Fan Bi Bi Bi Bi Bi Bi Bi Bi's "Research Report on the Reform of the Chinese Drug Supervision System"，A large number of imitations with quality and safety risks、Chinese patent medicine or even fake and inferior drugs，Local protection、Business bribery、False advertisements and other unexpected means entering formal channels，Including entering the national basic drug directory and medical insurance reimbursement directory。Some products are winning the bid，The price drops to the cost，Lack of Drug quality。The effect is precise、Drugs that have been strictly verified by scientific verification，If it is not suitable for the pharmaceutical industry & ldquo; hidden rules & rdquo;，It is difficult to promote application。Therefore, the phenomenon of & ldquo; phenomenon of inferior drugs expel good medicine & rdquo;，Wasting a lot of medical expenditures。

 

  China's current only quality guarantee、Medicine without drug protection，Become a gap between the generic drug and the original medicine。

 

  Make -up lessons of history

 

  Chinese generic drugs who have not been evaluated by the efficacy，Must be evaluated by the consistency of drugs。

 

  "Opinions" Requirements，New registration of chemical drugs to be approved before the implementation of chemicals，Anyone who has not been approved in accordance with the principles of My stake betting appStake Sports Bettingthe quality and efficacy of the original drug，All consistency evaluations must be carried out。National Basic Pharmaceutical Catalog (2012 Edition) The chemicals of chemical drugs for the listing before October 1, 2007，The consistency evaluation should be completed by the end of 2018，Among them, a variety of clinical effectiveness tests and special circumstances，The consistency evaluation should be completed by the end of 2021; if the overdue is not completed，Not registered again。

 

  An official of the State Food and Drug Administration said: & ldquo; Consistent evaluation of generic drugs that have been approved for listing，This is a lesson for history。The United States、Japan and other countries have also experienced the same process。& rdquo;

 

  & ldquo; The Chinese government has given the lowest entry threshold for medicines，After they have operated medicine for many years，Each enterprise should consider doing drug consistency evaluation，Responsibility for corporate liability。A 90%of a major imitation drug country that has not been rated by consistency，What is the reason not to do this work? The money also made you earn，Now I have no money to do experiments，Can you say it? & rdquo; An expert who participated in the document involved in the "Consistency Evaluation of the Make Drug" said。

 

  Preliminary statistics，Chemical drugs of chemicals and chemicals imitated drug oral solid preparations for the listing of listed before October 2007，There are 289 varieties in the basic medicine directory、17740 approval number or registration certificate number，involved 1817 domestic production enterprises、42 imported drug companies。

 

  & ldquo; consistency evaluation work，It is both a challenge and an opportunity for enterprises。Consistency Evaluation is a problem of life and death for enterprises，Is the process of survival of the fittest，How much is meaningless，Variety with the same quality efficacy as the original drug can have market value。& rdquo; The above official said。

 

  Surgery status

 

  After the Opinions are issued，Chinese pharmaceutical companies sigh。Do not do it，Choose life or death?

 

   & ldquo; Some old chemicals can no longer find reference reagents now，Some are dare not confirm，Some have found that you can't buy reference reagents。Another，Lack of scientific research capabilities for consistent evaluation，Lack of talents，In addition, time urgency，Condorite appears in clinical institutions。More than half a year passed，Many companies have not started this job yet。& rdquo; An expert in stake betting appA pharmaceutical industry describes the state of this war，Many companies are still watching and looking at。

 

  Xu Hengqiu, director My stake betting appof stake sports betting appthe Anhui Food and Drug Administration, said in an interview with the First Financial Daily: & ldquo;，But we set up a working group，Holding a corporate mobilization meeting，Building an industry -university -research technology cooperation service platform，Established a strategic alliance for the consistency assessment of generic drugs in Anhui Province，10 varieties have been started now。& rdquo;

 

  The consistency evaluation of generic drugs is not only an improvement of drug quality，It is also a big shuffle in the pharmaceutical industry。In the current existing 187,000 drug approval number，How many are sleeping? In this reshuffle，They will be eliminated forever。

 

  & ldquo; We have more than 120 medicine batch numbers，19 included in the basic drug directory，But only 3 varieties are producing。So we only want to make 5 varieties this time，Currently starting the consistency evaluation of 2 varieties，I will not do anything else。& rdquo; Ji Junyi, chairman of Hefei Cube Pharmaceutical Co., Ltd., told this newspaper。

 

  Ji Junyi said: & ldquo; The consistency evaluation cost of making a variety is 5 million to 10 million，If all of them are done，Pressure with the amount of funds，No need to。Some varieties are not competitive，Even if it is not produced，No need to do it，Only competitive in product species。& rdquo;

 

   & ldquo; Chinese lack of drug consistency evaluation，But they can entrust some scientific research institutions to do，Not there is no way。& rdquo; Experts from the above pharmaceutical industry said。

 

  For He Guangwei, Chairman of Hefei Medical Industry and Pharmaceutical Co., Ltd., which specializes in the development of new drugs,，This is undoubtedly a chance。& ldquo; In order to receive the consistency evaluation of the generic drugs entrusted，Our device has doubled，Invest tens of millions。At present, more than 20 varieties have been received for drug consistency evaluation。& rdquo;

 

  The consistency evaluation of generic drugs is a very complicated system engineering，Not only must you solve the huge investment of investment，What do you need to solve (selection varieties)、Who do it (independent research、Entrusted research、Cooperation Research) and how to do it (selection of reference preparations、Reverse Engineering Research、Prescription process improvement、Study on Evalent Equipment of Biology) Three major problems，Many influencing factors，The situation is extremely complicated。

 

  The most confused of the company is the change of specifications。& ldquo; The original research medicine is a pill，You imitate preparations，Unable to find the reagent of the parameter，This is stake betting appthe most troublesome thing。& rdquo; stake betting appA pharmaceutical industry person said。

 

   & ldquo; Many companies are entangled with how to choose reference reagents，Does your medicine do not know who you imitate? Indeed, there is a problem with the lack of clinical trial institutions，A hospital will do 10 to 20 varieties a year，Due to clinical trials requires daily blood、administration，The program is more troublesome。But the country has expanded a list of new clinical medical institutions that can be experimented with experiments。& rdquo; Experts from the above pharmaceutical industry said。

 

  At present, there are 53 medical institutions in the first phase of clinical trials，Workload for consistency evaluation，There is still lack of lack。According to industry insiders，Due to the large amount of clinical medical institutions required，The next step may cancel the GCP certification of the clinical medical institution，Change to filing。

 

  Experts formulated by the above participation in the consistency evaluation scheme of the generic drugs believe，& ldquo; Who can do it first，Who will benefit。Future Basic Drug Bidding will give priority，If you get it later, you will not enjoy this discount。And the current country has determined the varieties and batch numbers that do not make consistency evaluations，It will be canceled and cannot be produced again，This will be executed to the end。& rdquo;