The State Administration of Drug Administration announced on September 13 that "Opinions for the Evaluation of the Evaluation of the Consistent Evaluation of the Quality and the Consistent Effect of the Make Drug"，Application for supplementary applications to increase drug specifications is further submitted to strict requirements，That is, the generic drug must have the same active ingredients as the original research stake betting appmedicine、stake betting appThe same dosage form、The same way of giving administration、The same specifications; for the addition of specifications after improvement，You need to accept it according to the new drug。

 

  Due to robbing imitation、Patent and other reasons，Many pharmaceutical companies have the root of the original drug when developing generic drugs、Alkali base、Dosage form、Specifications, etc.，These historical problems are undoubtedly amplified in the context of consistency evaluation，Detailed Rules for the Evaluation of the Quality Consistency of the Medicine Drugs for the first time for the first time of the Drug Administration，undoubtedly improved the threshold of generic drug companies。

 

  This opinion point out，The change of the drug specifications should be within the range of the dosage of its clinical use，Under the same indications，Do not change the use of the original approval of the drug or the applicable population，Its specifications are generally not less than a single minimum dose，It must not be greater than the maximum dose of dosage。

 

  But，Pharmaceutical research needs to be changed with the reference preparation to be changed，Perform a comparison test，If the manufacturer also has the modified specification product that has passed the consistency evaluation stake sports betting appat My stake betting appthe same time，It should also be conducted，and evaluate the similarities and pros and cons of the two or three in each project。

 

  Research on the modified product and reference agent products to study，System comparison of various items related to security，Focus on the analysis of the confirmation and content of the material structure、Comparison test data such as the occurrence of impurities，Especially whether there are new degradable impurities and its impurities level and toxicity，and the comparative test of key items that can reflect the characteristics of their dosage types。

 

  1. In the case where the following conditions are met，It is recommended to choose the other specifications of the original research and the same variety as a reference preparation，Drug on the same dose，Test human biological equivalent test:

 

  (1) The indication and usage are the same;

 

  (2) In the range of therapeutic dose，Drugs present linear pharmacokinetic features;

 

  (3) The modification preparations are consistent with the activity components of the reference preparation，and the proportion of preparation prescriptions is similar;

 

  (4) Discover the in vitro dissolution of the specification preparations and reference preparations、Release features similar。

 

  2. Different specifications of the specifications of the above conditions，My stake betting appIt stake sports betting appis recommended to use clinical trials for evaluation。

 

   & ldquo; The introduction of consistency evaluation will change the current status of poor quality of domestic generic drugs，Due to consistency evaluation, it is called the most severe upgrade reform of the generic drug market，The General Administration of Food and Drug Administration will lead to the reshuffle and upgrade of most generic drug companies。& rdquo; Analysis of people in the industry，Many generic drug companies will die due to the threshold of the consistency evaluation of consistency，A large number of small and medium -sized enterprises face the challenge of closing the door。

 

  my country currently has nearly 7,000 pharmaceutical companies，Among them, more than 90%of the generic drug companies。According to statistics from the State Administration of Food and Drug Administration，The total number of drug approval numbers in my country is as high as 189,000，More than 95%is a generic drug。Due to the issues of standards and technical review requirements，The quality of some imitation drugs and the quality efficacy of the original product is not small.。

 

   The industry generally believes，Policy rules of the consistency evaluation of generic drugs gradually landed，The threshold for the approval of my country's new drugs will rise.stake sports betting app，My stake betting appAny assessment of any product in the future，Otherwise, I will face the doom of canceling the approval of the drug。