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 imitation drugs and original drugs in quality and efficacy，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 a pharmaceutical industry said。

 

  The distance between generic drugs and original drugs

 

  FDA (Food and Drug Administration) related documents of the United States，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, non -active ingredients can be different; indications with 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 medicine only requires a piece of amount，Eat 5 tablets in China，Want to reverse this situation，Improve the efficacy of Chinese imitation drugs，Only through drug consistency evaluation，And this is a common method internationally，It is also a must -have My stake betting approad。My stake betting appHistory，The government prescribed a mouth for generic drugs，I went on the road without doing medicine consistency evaluation experiments，Can't avoid this problem so far。The 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" drafted。

 

  In the absence of medicine and less medicine、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。and 7000 species approved、121,000 chemicals，Most of them are generic drugs。

 

  & ldquo; Compared with the original medicine，Imitation drugs are low in price，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 -producing countries。& rdquo; A pharmaceutical industry expert 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 unfair means entering formal channels，Including entering the national basic drug directory and medical insurance reimbursement directory。Some products are for winning the bid，The price drops to the cost，Lack of protection of drugs。Exact effect、Pharmaceuticals that have been rigorously 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 drug。

 

  Make -up lessons of history

 

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

 

  "Opinions" Requirements，New registration of chemical drugs to be approved before the implementation of chemicals，Over approval in accordance with the stake sports betting appMy stake betting appprinciple of consistent with the quality and efficacy of the original drug，All consistency evaluations must be carried out。National Basic Pharmaceutical Catalog (2012 Edition) In the chemicals of chemical drugs approved by October 1, 2007，The consistency evaluation should be completed by the end of 2018，Among them, a variety of clinical validity tests and special circumstances，The consistency evaluation should be completed by the end of 2021; if the overdue is not completed，Never registered。

 

   An official of the State Food and Drug Administration said: & ldquo; Consistent evaluation of generic drugs that have been approved for marketing，​​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，Take the responsibility of corporate。A 90%of a major generician country that has not undergone consistency evaluation，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 chemical generic drug oral solid preparations approved by October 2007，There are 289 varieties in the basic medicine directory、17740 approval number or registration certificate number，Involved in 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，The variety of quality efficacy and the original drug can have market value。& rdquo; The above official said。

 

  Surgery status

 

  After the Opinions are issued，Chinese pharmaceutical companies boo。Do not do it，Select 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，Condorities appear in clinical institutions。More than half a year passed，Many companies have not started this job yet。& rdquo; An expert in a pharmaceutical industry describes the state of this war，Many companies are still watching。

 

  The director of the Anhui Food and Drug Administration Xu Hengqiu said in an interview with the First Financial Daily: & ldquo;stake betting app，But stake betting appwe 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 evaluation of generic drugs in Anhui Province，10 varieties have been started now。& rdquo;

 

  The consistency evaluation of generic drugs is not only a renewal 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，The amount of funds has pressure，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 of 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 problem of huge investment，What else do you need to solve (selected varieties)、Who do it (independent research、Entrusted research、Cooperation research) and how to do it (selection of reference preparations、Research on Reverse Engineering、Prescription process improvement、Study on Equal Equipment of Biology) Three major problems，Many influencing factors，The situation is extremely complicated。

 

  What confuses the company is the change of specifications。& ldquo; The original research medicine is a pill，You imitate into a preparation，15996_16005，This is the most troublesome thing。& rdquo; A person in the pharmaceutical industry said。

 

   & ldquo; Many companies are entangled with how to choose reference reagents，Did you not know who did Stake Sports Bettingyou Stake Sports Bettingimitate? Indeed, there is a problem with the lack of clinical trial institutions，A hospital will do 10 to 20 varieties a year，Because clinical trials need to draw blood per day、administration，The program is more troublesome。But the country has expanded the list of new clinical medical institutions that can be experimented with experiments。& rdquo; Experts of 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。

 

  The experts who participated in the formation of the consistency evaluation plan of the generic drug above believe，& ldquo; Who can do it first，Who will benefit。In the future basic drug bidding will give priority，If you get it later, you will not enjoy this discount。And the current country has identified 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;