August 20, 2016，Deputy Director of the State Food and Drug Administration, Sun Xianze, pointed out: & ldquo; The assessment of the consistency evaluation of the quality and efficacy of the generic drugs is being transferred to the full evaluation stage。& rdquo;

 

  Determining the consistency evaluation of the generic drugs that decide the life and death of pharmaceutical companies is currently being promoted in the hotter，The progress of this work is undoubtedly the most concerned thing in the pharmaceutical industry。

 

  August 20, 2016，Deputy Director of the State Food and Drug Administration, Sun Xianze, attended & ldquo; Chinese Medical Enterprise Management Association、China Medicine Anti -presidential Pharmaceutical Association Vice President Association and China Pharmaceutical 50 Persons Forum & rdquo;，During the period, he made a report with the theme of the theme of the drug supervision innovation and the supply side of the pharmaceutical industry and the supply side of the pharmaceutical industry.。In the report，He sorted out policies for the consistency evaluation of generic drugs，and point out: & ldquo; Evaluation of the quality and efficacy of generic drugs is being transferred to the comprehensive evaluation stage。& rdquo;

 

  He emphasized at the same time，To speed up the consistency evaluation work of generic drugs，Promoting the structural reform of the supply side of the Chinese pharmaceutical industry，Driving the pharmaceutical industry from Chinese manufacturing to China created transition，The speed of the speed from China to China，and change from products from Chinese products to Chinese brands。

 

  stake online sports betting1 Encouragement policy is gradually implementing

 

  Previous，State Council、CFDA、The Chinese Inspection Institute has released a series of guidance or principles，Various links involved in consistency evaluation，Also includes various encouragement measures。Sun Xianze said at the meeting，Hope that pharmaceutical companies must make good use of relevant encouragement policies。

 

  For example, CFDA has passed the decline in politics、Implement the record system for biological equivalent test、Establishment of consistency evaluation materials and drug registration supplementary applications Establish review green channels and other methods to encourage pharmaceutical companies to carry out evaluation work。

 

  For another variety for domestic drug manufacturers to complete the registration of registered and listed in foreign countries，National Bureau encourages enterprises to return to domestic registration，After passing the information review and production site inspection，It can be regarded as passing the consistency evaluation。This is for domestic such as Huahai Pharmaceutical、Hai Zheng Pharmaceutical and other pharmaceutical companies that go abroad are good opportunities。

 

  Sun Xianze also emphasized，Variety of consistency evaluation，Production enterprises can apply for the pilot work and commission processing of the holder system of the listing license holder，You can also transfer the approval number。Earlier，The State Council has issued the "Pilot Plan for the Pharmaceutical License of the Pharmaceutical License"，Provide policy basis for the listing licensee and commission processing。

 

  In addition，Sun Xianze revealed，Evaluate the logo and logo through consistency evaluation，It has been designed by the Chinese Inspection Court，It is reporting to the General Administration of Industry and Commerce。The logo stipulated by the printed drug supervision department in the instructions and labels，Convenient for public recognition and use of medical institutions。

 

  Zhang Zhijun, deputy dean of the China Food and Drug Inspection Research Institute who attended the forum at the same time, also revealed，Next，"Pharmaceutical Inspection Institution Compliance with the Inspection Requirements" and "Clinical Effective Test File Procedure" are also being discussed internally。

 

  Industry insiders pointed out，With these supporting files,，Basic allocation of relevant policies for the consistency evaluation of generic drugs，The company stake sports betting apphas all entered the life and death field，Enter the countdown。

 

  2 Troubleshooting is being broken

 

  Evaluation of the consistency evaluation of generic drugs，The company also faces many practical problems。On the forum，Zhang Zhijun pointed out the difficulties faced by the enterprise in the actual implementation process，For example, tight、Mission weight、Difficulties in the selection of reference preparations、Difficulty，and the shortage of clinical trial institutions and high prices。

 

  The good news is，Sun Xianze and Zhang Zhijun revealed，CFDA has recently sorted out policies and technical issues faced by more than 30 pharmaceutical companies，will make a explanation in the recent public。

 

  Where，What the industry responds stronger is the problem of clinical resources shortage，Affects the work progress。For this，Sun Xianze said，The country is also considering or changing from the certification system to the filing system。Earlier，CFDA has implemented filing management for some eligible chemicals and biological equivalent tests。According to disclosure，CFDA is also considering simplified administration and decentralization，Authorized biological equivalent tests to the Provincial Bureau Management。The clinical trial filing is not changed when the Drug Management Law is not changed，Also authorized the National People's Congress。According to the E -drug manager,，The institutional reform authorized by the National People's Congress at present，Only the listing license holder system。

 

  In addition，To accelerate the progress of the work of pharmaceutical companies，Help enterprise solve practical problems，CFDA has done 7 training in the first half of the year。According to Sun Xianze Introduction，Next CFDA will continue to carry out related free training，Such as the acceptance and evaluation of data，On -site inspection，Clinical verification and reference preparations, etc.。

 

  He also said，The current imitation drug consistency evaluation office and the drug review center are jointly promoting the work。It is reported，Drug Examination Center currently has more than 230 people，Plus 330 people in the provincial bureau，Next, there will be a significant recruitment of talents，Fighting 600 people at the end of the year。

 

  Earlier in medical insurance payment and bidding、Encouragement policies in clinical applications and other aspects of medical insurance are needed、Bidding and other departments My stake betting appare questioned。For this，Sun Xianze said，CFDA has already been with the Health and Family Planning Commission、The Ministry of Human Resources and Social Affairs and other relevant departments reached an agreement，Jointly promote the consistency evaluation work of generic drugs。& ldquo; Just pass the consistency evaluation，Regulatory authorities will immediately abandon the separate purchase of imported drugs，Put the generic drug with the original drug on the same platform。& rdquo;

 

  In addition，In terms of project funds，Development and Reform Commission、The Ministry of Finance and the Ministry of Industry and Information Technology are increasing policy capital support，Adopting the Industrial Development Fund and the replacement of awards、Technical reform subsidy、Loan discounts and other methods，Support manufacturers to carry out consistency evaluation work。It is reported，At present, Heilongjiang Province has provided a lot of funds to support some enterprises to carry out consistency evaluation work，Sichuan Province also gives funding support alone for some varieties。

 

  3 Understand enterprises to accelerate the exclusive variety of exclusive progress, special attention

 

  A few days ago，CFDA announced 289 consistency evaluation varieties，Including 17,740 approval number。The introduction of this directory，It is considered to help pharmaceutical companies have a clearer understanding of the specific situation of manufacturers and varieties of the consistency evaluation of generic drugs，Make pharmaceutical companies choose more valuable varieties in a targeted manner，Maximize the benefits of resource use。

 

  Sun Xianze said at the meeting，Announce the variety directory that needs to be evaluated，In fact, it is also to let all companies look at，Do not do it if you do it，Then urge pharmaceutical companies to promote the progress of the consistency evaluation work of generic drugs as soon as possible。

 

   & ldquo; The problem of overcapacity is vividly performed among 289 varieties，The average yield of all varieties is only 25.22%，Many products have not produced for many years，Actually it is the chicken ribs of the enterprise。& rdquo; Sun Xianze said。

 

  It is worth noting that it is，There are 2 to 3 varieties of the approval number in the directory.，Only 23 are 1 piece。For this，Sun Xianze reminded relevant companies not to drop the chain，To speed up the evaluation progress。

 

   & ldquo; The food and drug regulatory authorities will establish a quarterly table for next，Timely report the evaluation results of the same variety，stake betting appSlowly evaluating the progress of evaluation，varieties that may affect market supply，Relevant departments should increase funds and technical guidance，Make sure the availability of clinical medication。If there is an enterprise,，It will be announced，Consider included in the clinical shortage catalog，Encourage other manufacturers to imitate。& rdquo; Sun Xianze said。

 

  He also reiterates the goal of the consistency evaluation of generic drugs at the same time: First, improve the overall level of the pharmaceutical industry，Ensure that the public medication is safe and effective; followed by promoting the supply -side reform of the pharmaceutical industry，Promoting the adjustment of the industrial structure; the third is to enhance international competitiveness，Promote domestic drugs to the world。