In order to implement the "Opinions of the General Office of the State Council on the Evaluation of Consistent Evaluation of the Quality and Consistent Effectiveness" (National Office [2016] No. 8)、Announcement of the General Administration of Food and Drug Administration on the implementation of the "Opinions of the General Office of the State Council on the Evaluation of the Evaluation of the Quality and Consistent Effect of Photos" (Relevant requirements for the Evaluation of Consistency of the Quality and Consistent Effects "(No. 106, 2016)，The State Administration of Food and Drug Administration organized the drafting of the "Consistency Evaluation of the Quality and Consistency of the Make Drugs and the Evaluation of Specifications for Specifications (Draft for Soliciting Opinions)，Now publicly soliciting opinions from the society。Please refer to the revised opinion on October 15, 2016 to the State Food and Drug Administration through email。

 

  Email: chp_fzypj@chp.org.cn

 

  Attachment: The consistency evaluation of the quality and efficacy of generic drugs is generally considered (soliciting opinion draft)

 

  The General Office of the State Administration of Food and Drug Administration

 

  September 13, 2016

 

  Annex

 

  Consistency of the quality and efficacy of generic drugs.

 

  In order to implement the "Opinions of the State Council on the Approval My stake betting appstake sports betting appSystem of Reform of the Reform of the Medical Device Review and Approval" (Guo Fa [2015] No. 44) and the Opinions of the General Office of the General Office of the State Council on the Evaluation of Consistency of the Quality and Consistent Effect of Photos (State Office [2016] No. 8) spirit，The State Administration of Food and Drug Administration issued the announcement on the implementation of the "Opinions on the Evaluation of the General Office of the State Council on the Evaluation of the Quality and Consistent Effects of Photos" ( Select and determine the Guidance Principles "and other technical guidance principles，This article is a supplementary document for the above guidance principles。

 

  Change specifications refer to this specification in the European Union、The United States or Japan has not been approved to be listed or has been approved to be available.。This article is applicable to the evaluation of specifications in the evaluation of the quality and efficacy of generic drugs。The evaluation of changing the specifications of drugs includes but not limited to the content described in this article。

 

  1. Overview

 

  Current，Some of the drugs that have been approved by my country have some changed specifications products，The re -evaluation of this part of the product is an important part of the evaluation of the quality and efficacy consistency of the quality of the drug。Due to the specifications and dosage of drugs, it is determined based on clinical trials before listing，Therefore, increase specifications general。To strengthen the management of drug specifications，Prevent unreasonable drug specifications bring confusion to clinical medication，Former State Food and Drug Administration issued the "Notice on Strengthening the Management of Drug Specifications and Packaging Specifications" (Food and Drug Administration Note [2004] No. 91)，Further application for supplementary applications to increase drug specifications，If the specifications applying for the application must not change the original usage dosage or the applicable population。The requirements of the new chemical drugs released by the State Food and Drug Administration in 2016 The requirements for generic drugs are consistent with the US stake betting appFood stake betting appand Drug Administration，That is, generic drugs must have the same active ingredients as the original drugs、The same dosage form、The same way of administering、Same specifications; for the addition of specifications after improvement，Need to accept it according to the new drug。The evaluation of the medicines for changing specifications includes many aspects such as pharmacy and clinical trials。

 

  2. Evaluation content

 

  (1) The scientific and rationality of the existence of the specifications of the specifications of the specifications

 

  If the corresponding specifications of the original research drug have been approved but no longer exist or the original drug has never been approved by this specification，First of all, the listing situation of other specifications of the same specifications of the same variety，Fully demonstrates the scientific nature of the existence of specifications for the existence of specifications、Reasonable and necessity。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。

 

  (2) Pharmacy research

 

  Pharmaceutical research needs to be changed with specifications with the reference preparations，Perform a comparison test，If the manufacturer also has the modified specification product that has passed the consistency evaluation at the same time，It should also be conducted，and evaluate the similarities and pros and cons of the two or the three in each project。The research content mainly includes the following aspects:

 

  1. Prescription composition and process research

 

  Brief analysis of the key material and chemical characteristics related to preparation performance，Through the raw supplementary material、Comparison of prescriptions and processes，Prove the scientific and reasonableness of the prescription and process。

 

  2. Quality standards stake online sports bettingand stake betting appquality control: Research on the modified product and reference preparation products，System comparison of various projects related to security，Focus on the analysis of the confirmation and content of the material structure、Comparison test data such as the generation 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 forms。

 

  3. Increase the stability test of specifications products.

 

  (3) Study or clinical trial

 

  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 administration with the same dose，Perform 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 activity component of the modification preparation is consistent with the active components of the reference preparation，and the proportion of preparation prescriptions is similar;

 

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

 

  2. Do not meet the above conditions to change the specifications of the specifications，It is recommended to use clinical trials for evaluation。

 

  3, other

 

  For other unspecified matters, please refer to the "Notice on Requirement of the Requirement of the Requirement of the New Registration and Classification Classification Classification Classification Classification Classification Classification Classification Requirement (Trial)" (2016 No. 80)、"Notice on the Requirement Requirement Requirement Requirement (Trial) Requirement (Trial) (Trial) (2016 No. 120)、"The Principles of the Research Technical Guidance Principles of Chemical Drug Imitation of Pharmaceutical Parameters as the Evaluation Index" (announcement of the State Food and Drug Administration announced the 61st 2016) and "The quality and efficacy of generic drugs and efficacy are consistent Stake Sports BettingSexual stake online sports bettingevaluation clinical effectiveness test generally considered "formal documents such as formal documents。