What is the purpose of consistency evaluation? Previous，Sai Bailan once analyzed when sharing the article，Consistency Evaluation，The most important thing is to complete the quality of drugs，Once the quality of the medicine is completed，Original research drugs will be the biggest impact。The consistency evaluation of generic drugs is imperative，Enterprises must make a choice，The most important thing to do is choose a good variety。The large cleaning of the text number has arrived，There may be more than 10,000 texts that will disappear。

 

  The above two judgments are basically confirmed in the recent speech of Director Bi Jingquan, the State Food and Drug Administration。

 

  June 21-22，The State Food and Drug Administration held in Beijing to hold the quality and efficacy consistency evaluation work meeting in Beijing，Implement the opinions of the State Council on the evaluation of the consistency of the quality and efficacy of the State Council，In -depth promotion of the reform of the drug review and approval system。Director of the General Administration Bi Jingquan attended the meeting and spoke。

 

  The consistency evaluation of generic drugs is survival of the fittest

 

  Sai Bailan got the full text of the speech from the source，In speech，Bi Jingquan said，The consistency evaluation of generic drugs will promote the adjustment of the domestic pharmaceutical industry structure，The quality of generic drugs has been improved，Clinically achieved mutual replacement with the original research medicine，stake betting appMy stake betting appChange the current proportion of drug sales of the original drugs in some large hospitals reaching 80%，It is conducive to reducing total medical stake online sports bettingstake betting appexpenses，It is conducive to eliminating backward production capacity，Improve the competitiveness of domestic generic drugs。

 

  Bi Jingquan said in his speech，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 and efficacy is consistent with the original research only has market value。For varieties，Enterprises must make a choice。Several varieties of a company have successful，Add the implementation of the holder system of the listing permit，You can get the opportunity in the competition。

 

  Reference Preparation，Responsibility in pharmaceutical companies，Pharmaceutical companies should act quickly!

 

  In speech，Bi Jingquan also focuses on the issue of reference preparations，The main responsibility for looking for the reference preparation is the enterprise，General Administration、Provincial Bureau、Industry Association to provide guidance and help。Questions that occur in the actual operation of the enterprise，Bi Jingquan expressed an objective existence，But to analyze objectively，Why do we still use the varieties that have been delisted abroad? Why did the original research product change the dosage type here、specifications?

 

  From the above speech, you can see，Evaluation of consistency，Pharmaceutical companies should no longer delay! The reason is no longer the reason，Responsibility in pharmaceutical companies，Early hand is the last word!

 

  Bi Jingquan also revealed，To solve the problem of tight clinical experimental agencies，Future clinical experiments will be adjusted by qualification identification to filing management，It is currently soliciting opinions from relevant departments。

 

  For companies that are not consistent evaluations，Bi Jingquan also pointed out the direction，Enterprise that is not consistent evaluation，You can use your own advantages to engage in the commission processing of drugs。

 

  The following is the PDF file in PDF file provided by Saibailan from the news provided by the source，Pick out and consistent evaluation related content:

 

  First，The consistency evaluation of generic drugs is a major measure to promote the structural reform of the supply side。Product quality is the supply side problem，How to better meet the problems of market demand，It is also a structural problem。The quality of generic drugs has been improved，Clinically achieved mutual replacement with the original research medicine，It can promote structural change in the field of drug production，stake betting appMy stake betting appChange the current proportion of drug sales of the original drugs in some large hospitals reaching 80%，It is conducive to reducing total medical stake online sports bettingstake betting appexpenses，It is conducive to eliminating backward production capacity，Improve the competitiveness of domestic generic drugs。

 

  Second，Consistency evaluation is a way that many countries have gone。History，Pay attention to the test ingredients for medicines。1906 The United States promulgated the Food and Drug Act，It mainly cracks down on adulteration、Counterfeit。1971 The United States launched an equivalent evaluation of generic drugs and biology，Start paying attention to the efficacy of generic drugs。

 

  1984 The United States issued a bill for generic drugs，Speed ​​the pace of the listing of generic drugs。Japan launched the drug quality re -evaluation project in 1997。my country's 2001 Drug Management Law，Cultivation of generic drugs into the national unified approval，Start requiring generic drugs for clinical trials; in 2007, imitation of original research medicines，but not for compulsory requirements。

 

  In 2012, the State Council issued drug safety & ldquo; 125 & rdquo; plan，Proposed the mission of the quality consistency of the quality of generic drugs and the original drug; last year, the State Council No. 44 proposed the requirements of quality efficacy and the consistency of the original drug。Consistency Evaluation，It is a supplementary lesson in my country，Also innovation。Be consistent with the quality and efficacy of the original drug，We are not far away from creating new medicines。

 

  Third，Enterprises must have a job。Preliminary statistics，Chemical drugs for chemical drugs approved by October 2007，There are 289 varieties in the CCP of the Base Medicine Catalog、17740 approval number or registration certificate number，Involved in 1817 domestic production enterprises、42 imported pharmaceutical companies cannot do so many pharmaceutical numbers，Can't do it，No need to。

 

  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 and efficacy is consistent with the original research only has market value。Enterprises should choose the most confident variety，Pay crystal、Accessories、Crafts and other basic research，Take the laboratory External dissolving test，Renewal biological utilization clinical trial，Take less detours。Several varieties of a company have successful，Add the implementation of the holder system of the listing permit，You can get the opportunity in the competition。

 

  Fourth，Select Reference Preparation。File Requirement Reference Preparation In principle, the original research medicine，You can also choose the internationally recognized medicine。Enterprise reflection，Some varieties in the basic drug directory may not find the original research。Some say that the original research variety has been delisted and not produced; some say that the dosage form is changed、Change specifications、stake online sports bettingstake online sports bettingChange the root、The variety of alkali base，Can't find the corresponding original medicine or internationally recognized varieties as reference preparations。These situations do exist objectively。But why do we still use the varieties that have been delisted abroad? Why did the original research product change the dosage type here、specifications? Analysis of these opinions。

 

  The main responsibility for looking for the reference preparation is the enterprise，General Administration、Provincial Bureau、Industry Association to provide guidance and help。There is controversy in the reference preparation，The General Administration can organize experts to publicly demonstrate。The General Administration organized 36 inspection institutions such as the Chinese Inspection Institute to conduct 75 basic drug varieties in vitro dissolution and pharmaceutical research，You can provide your reference。

 

  Fifth，Hurry up to solve the problem of lack of clinical trial resources。There are 475 clinical drug test agencies that are currently qualified by the General Administration of General Administration，Concentrated in the third -level hospital。The General Administration has communicated with the State Health and Family Planning Commission，The General Administration has communicated with the State Health and Family Planning Commission，Announcement has been drafted，Opinions of the relevant department are asking the relevant departments。

 

  After implementing the record management，The contradiction of tight clinical trial resources can be relieved。Some reflected high clinical trial costs high，This should be analyzed for specific analysis。Overall，Clinical trials to occupy medical resources，Clinical trial costs must not only compensate the salary cost of medical staff，Also compensate the hospital's opportunity cost，This can mobilize the enthusiasm of medical staff。

 

  Sixth，What should I do if some enterprises do not have consistent evaluation? Drug production capacity in my country is serious excessive，Excessive number of enterprises。Some enterprises are not consistent evaluation very normal。Pharmaceutical companies through consistency evaluation，It can be used as a list of drugs for drugs to entrust other companies to produce; enterprises that are not consistent evaluation，You can use your own advantages to engage in the commission processing of drugs。The key is that the company must find a position。

 

  Seventh，Pay attention to all places。Consistency Evaluation Work This hard task，There are quality requirements、There are quality requirements。Pay attention to all places，Director must get started stake betting appStake Sports Bettingin person，Strengthen leadership，Coordinated coordination，Improve the working mechanism，Research and solve the problems encountered in the work。To report to the party committee and government for actively，Follow the support of relevant departments。A technical guidance group can be established at a conditional place、Expert Guidance Committee and Review and Examination and Coordination Group，Provide technical support for the company's consistency evaluation。