Recently, CDE gave pharmaceutical companies a good good.

 

  July 21，The National Bureau of Pharmaceutical Review Center issued a very concise "& ldquo; the first imitation & rdquo; the basic principles of priority review and evaluation。Principles Total 249 words。In the sense of release，This file is more like a notification letter for adjustment of departmental work plan。CDE proposes the definition of & ldquo; first imitation & rdquo; definition，and incorporate the application registration of the first imitation into the priority category。This will greatly speed up the listing process of the first imitation drug。

 

  The first imitation medicine needs to meet the following stake sports betting appstake online sports bettingconditions at the same time:

 

  (1)   There is only one import of the same variety in the same variety;

 

  (2)   To be reviewed in the same variety，The sequence of the dates of the hosting center of the Drug Review is the first one;

 

  (3)   It has exceeded the statutory review period.

 

  There was no official definition before the first imitation medicine

 

   & ldquo; The first imitation & rdquo; concept originated from the concept of the United States's first imitation，"Hatch-WAXMAN Amendment) Regulations，In the case of patent invalid or approved drugs that are applied to be applied for infringement & rdquo;，The first imitation applicant will have a market monopoly right of 180 days，During this period，FDA no longer approves the same Anda (new drug listing application)。

 

   & ldquo; The first imitation drug & rdquo;，According to the "Work Plan for the Reform of Chemistry Classification Classification Classification Reform" released by the State Administration in March 2016，The first imitation drug does not exist in the above protection period。& ldquo; The first imitation drug & rdquo; value more reflects the bidding of medicines，extra points for the technical score of the dual -envelope system。

 

  In 2005, the Development and Reform Commission proposed the concept of imitation in the "Administrative Measures for Drug Price"，Definition of drugs that are first imitated and sold in China。In the article "Measures for Drug Price" released by the National Development and Reform Commission in 2006 (draft for comments)，The concept of official proposed separate pricing drugs，Point out & ldquo;，After demonstrating the expert，Allows to appropriately float on the basis of stake online sports bettinga stake online sports bettingcertain price: & hellip; & hellip; domestic first imitation production and listing & rdquo;。According to the separate pricing identification process organized by the price department，It is demonstrated by experts to determine whether the product declared by the enterprise is the first imitation，to get a separate pricing qualification。

 

  In the subsequent provinces bidding documents，The first imitation drug & rdquo;、& ldquo; separate pricing drugs & rdquo; listed as a higher quality layer，Implement a separate bidding group，or a certain premium treatment。

 

  Since the data between departments is not effectively connected，The definition of the first imitation medicine is updated in the bidding documents of each province，Connotation continues to extend，Whether it is the first imitation in my country does not have an official definition standard。The qualification identification is mainly reviewed by the provincial bidding office in accordance with the materials and submitted by the provincial bidding office，It is defined as the first imitation drug after the document is not questioned。

 

  But the first imitation drug identified by the provincial bidding rules，General requirements: the first medicine that imitates foreign patent technology，Approve the approval time of the National Food and Drug Administration，Drafting certificate of combination of quality standards，Domestic medicines that hold new drug certificates at the same time。

 

  The rules of the first imitation drug are broad, good

 

  and the first imitation drug & rdquo; priority review list released by stake sports betting appCDE，stake sports betting appThe products listed are mainly 6 categories of registration (that is, imitation of domestic drugs in China)，Far wide than the original rules of various provinces。

 

  From the perspective of bidding，If a family of imports coexist with the first domestic imitation manufacturer，Import manufacturers with expired original research single column，Domestic manufacturer's quality level group belongs to exclusive，At this time, domestic manufacturers hope to obtain longer exclusive periods instead of & quot;。

 

  Only the first & quot; the manufacturer also hopes to obtain the price advantage and the single supply of the bidding for the bidding for the bidding for the bidding.。Promoting the regulations of consistency evaluation，The quality of the bidding of drugs is more concerned about whether it is appraised through consistency。

 

  Conclusion: The first imitation is determined by CDE, the bidding is good

 

  CDE has an important condition in the definition of the first generic drugs: it has exceeded the legal review period。This definition indicates that only exceeding the registration time can compensate for treatment，This means that if the first imitation drug approved for normal application is not accelerated。Therefore, this drug registration policy that has caused more rules today，It may be just a short -term policy。For some medicines produced by many companies，In the qualification identification of drug bidding，Maybe you can get some bidding advantages through this definition of CDE。

 

  Attachment: The list of priority review of the first imitation and the market sales scale (10,000 yuan) in 2015