One of the two major difficulties in the consistency evaluation of generic drugs，It has always troubled many companies。More than 2,000 reference preparations filing and declaration in CFDA are also chaotic。Now CFDA gives detailed standardized guidance plans，Can it solve the urgency of the enterprise?

 

  November 29，CFDA issued the "Guiding Opinions on Further Standardizing the Selection of Consistency Evaluation Reference Preparation Preparations for the quality and efficacy of generic drugs"，The main choice and determination of the reference preparation，The obtaining channels of the reference preparation have been regulated and guided。

 

  Selection and OK of the reference preparation

 

   (1) Choose the domestic marketing drugs as a reference preparation，Perform in the following order:

 

  1. Preferential selection of the original research listing license to hold manufacturers' origin import products。

 

  2. Choose the original research listing license to hold the manufacturer's other origin of imported stake online sports bettingproducts，My stake betting appBut this product must be in the European Union、The United States、Listing in Japan，and have the status of reference preparations。The original listing license to hold the manufacturer and the place of origin changed，It is necessary to prove that it is the original product，and in the European Union、The United States、Listing in Japan，and have the status of reference preparations。

 

  3. The above two items can still be determined，You can choose internationally recognized the same drug as a reunification preparation。

 

   (2) Choose the drug varieties that are not listed in China as a reference preparation，Perform in the following order:

 

  1. Preferential selection of the original research listing license to hold the manufacturer's origin products。If the original research product has other origin，This product must be in the European Union、The United States、Listing in Japan，and have the status of reference preparations。

 

  2. Selecting internationally recognized the same drug as a reference preparation.

 

   (3) The varieties of the original research enterprise produced and listed in China:

 

  1. The original domestic real estate product produced by the same production line，At the same time in the European Union、The United States or Japan is listed，Provide confirmation information from the original research My stake betting appenterprise，According to the "Guidance Opinions on the Classification of Consistency of the Quality and Consistency of Make Drugs" (being soliciting opinions，The following referred to as specified guidelines in the following abbreviation)，Prove that the original research domestic real estate products are consistent with the quality and efficacy of the original drugs，After being reviewed and determined by the Expert Committee and released by the State Administration of Food and Drug Administration，Choose as a reference preparation。

 

  2. The original research domestic real estate products and the prescription process of the original product did not change，Provide confirmation information from the original research My stake betting appenterprise，According to the procedure Stake Sports Bettingdescribed in the guidance of the variety category，Prove that the original research domestic real estate products are consistent with the quality and efficacy of the original drugs，After being reviewed and determined by the Expert Committee and released by the State Administration of Food and Drug Administration，Choose as a reference preparation。

 

  3、Original research domestic real estate products and the prescription process of the original products have changed，Its production enterprises need to prove that real estate products are consistent with the quality and efficacy of the original product，According to the procedure Stake Sports Bettingdescribed in the guidance of the variety category，Prove that the original research domestic real estate products are consistent with the quality and efficacy of the original drugs，After being reviewed and determined by the Expert Committee and released by the State Administration of Food and Drug Administration，Choose as a reference preparation。

 

  4、Original research domestic real estate products and the prescription process of the original products have changed，Its manufacturers cannot confirm consistency，It is necessary to determine another foreign research drug reference preparation。

 

   (4) Change specifications、Modified dosage type、The imitation varieties of salt -based modification are generally considered in accordance with the "Evaluation of the Consistent Evaluation of the Quality and the Consistent Effect of the Make Drug" (to be released)、"Evaluation of the Evaluation of the Modeling of the Quality and the Consistency Evaluation of the Make Drugs (General Oral Oral Solid Preparation) is generally considered" (to be released)、"General consideration of the Evaluation of Salt Pharmaceuticals in the Evaluation of the Quality and Effects of the Make Drug" (to be released) (to be released) requirements，Select Reference Preparation。

 

  The way to get the reference preparation

 

   (1) Enterprise purchase independently。Drug production enterprises are the main body of the consistency evaluation of the quality and efficacy of generic drugs，Should buy a reference preparation。You need to buy from abroad，After verification of the specifications of the list of consistency evaluation varieties，According to the "Announcement on Research Research on Research stake sports betting appMy stake betting appResearch in Research in the Research Research Research Research Process" (announcement of the control drugs at one time "(No. 120, 2016)，Use a one -time import method。

 

  (2) Entrust third party purchase。Encourage third -party trading companies with import and export qualifications to provide reference preparation procurement services。Food and Drug Administration can also publicize the relevant information related to the reference preparations，For enterprise reference。

 

  (3) Assisting enterprises to buy。Special varieties、varieties that cannot be purchased through market channels，It can be negotiated by the Food and Drug Administration through the intergovernmental cooperation channels and the original research enterprise.，Assisting companies to buy。

 

  Selection of the reference preparation，CFDA has successively introduced the "Principles of the Selection and Determination of Guidance of General Oral Oral Solid Preparation Preparations" (Notice No. 61, 2016)、"Announcement on the Research Reference Preparation and Recommendation Procedure of the Consistent Evaluation Reference Preparation and Recommendation Procedure (2016 No. 99) and other documents，Clarified the selection principle of the reference preparation，filing、Recommended and declared procedures。

 

  This document is mainly aimed at the existence of the original research drugs、Change the place of origin，Various situations such as imported drug realization，To provide guidance principles for the selection of reference preparations in the evaluation of the quality and efficacy of the quality of the generic drugs。