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The consistency evaluation of generic drugs enters the implementation stage
Release time: 2016-08-05 & nbsp & nbsp & nbsp Source: Anonymous
  The so -called consistency evaluation,It is a level that is consistent with the quality and efficacy in terms of quality and efficacy。
 
  Many generic drugs in my country are not dispute over the clinical efficacy of the original drugs,Therefore, many patients would rather spend several or even tens of times the price of imported original drugs.。This makes many domestic generic drug companies in order to win market sales,I have to play a big product price war。
 
  But,The result of malignant competition has always been compressed by corporate stake online sports bettingStake Sports Bettingprofit margins,Can't maintain the benign development model of the international & ldquo;。As the patient feels like,Today, the situation of Chinese generic drug companies is a bit bad,A little tangled,A bit helpless。
 
  Anxious situation for generic drug companies,The State Council issued the "Opinions on the Evaluation of the Consistency of the Quality and Effects of Photics and Consistent Effects" in March this year,It is required to approve the listing of listing before October 1, 2007、Chemical drugs in the National Basic Pharmaceutical Catalog (2012 Edition),In principle, the consistency evaluation should be completed by the end of 2018。
 
  immediately,The State Drug Administration issued the "Announcement on the Release of Work Procedures for the Evaluation of the Quality and Effects of Make Drugs" in May,It specifies that the enterprise completes the consistency evaluation process,Analysts at the time pointed out,The consistency evaluation of generic drugs will enter the substantive stage in the second half of this year。
 
  In this "List of Nuclear Inspection Institutions",Beijing Drug Inspection Center、Tianjin Drug Inspection Center、Hebei Pharmaceutical Inspection Research Institute、Guangzhou Drug Inspection Center、Qingdao Food and Drug Inspection and Research Institute, including 38 institutions, etc.。
 
  They assume consistency evaluation and supplementation My stake betting appstake betting appof drug inspection institutions for review and inspection,After receiving the application information and three batches of samples, review and test,And the review and inspection results of domestic imitation drugs are submitted to the provincial food and drug supervision and management department of the drug manufacturer where the drug manufacturer is located;。
 
  What are the work of the consistency evaluation of generic drugs?
 
  Consistency Evaluation Office is responsible for consistency evaluation work,Organize experts to review and determine the reference preparation; evaluate the consistency evaluation data submitted by the enterprise;
 
  Consultation and guidance of relevant policies and work procedures,Consultation and guidance of the technical requirements of the Organizational Drug Examination Center on the technical requirements of biological equivalent tests and clinical validity tests;
 
  Responsible for organizing inspection centers for inspection of production site、Technical requirements for the research and development site verification and clinical verification of the work for consultation and guidance;
 
  Responsible for organizing the China Food and Drug Inspection and Research Institute and the drug inspection institutions that undertake the review and inspection work.。
 
  China's pharmaceutical industry is facing transformation and upgrading
 
  2015 global pharmaceutical market scale (excluding medical equipment) is stake online sports bettingabout stake betting app$ 1068.8 billion,Global pharmaceutical sales will maintain 4%to 7%in the next 5 years。Current Chinese pharmaceutical companies are transforming,Starting from the low value -added products of the community to the characteristic raw material、Patented Pharmaceutical、Turn on biopharmaceuticals。
 
  This can be seen,A huge market is placed in front of the pharmaceutical industry。But,To achieve the growth of this market,Pharmaceutical companies need to pay attention to the management of the quality efficacy of the drugs produced,Constantly improve the technical level,Enhanced independent innovation ability,thereby improving the overall technical level and high -end manufacturing capabilities of my country's pharmaceutical industry。
 
  Current,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 in。
 
  From the long run,It is a good thing to evaluate through consistency.,But for the industry,In the next 5-8 years, it will be the most painful & ldquo; pain period & rdquo;。