a、Reference Preparation Selection Question: It is difficult to determine or discontinued for the original research variety、delisting，The United States and Japan has no related RLD (Reference List Drug) product。

 

  Answer: According to the "General Administration of the General Administration on Implementing the Evaluation of the Evaluation of the Quality and Consistency of the Makeup Drugs and the Consistency of the Consistent Effects of the State Council;，The company cannot find it and cannot determine the reference preparation，Performing clinical effectiveness tests from drug manufacturers。

 

  2、Specifications: domestic listing products and original research、Foreign -listed product specifications cannot be completely consistent，or the reference preparation is only one of the specifications of listed products。

 

  Answer: The General Administration has published the "Evaluation of the Modified Date (General Oral Oral Solid Institution) Evaluation" (general consideration for comments)，After the formal document is formed, it can be evaluated according to the requirements in the file。

 

  3、Reference Preparation Procurement Problem: When the original research drug industry cannot be purchased、When multiple batch of medicines cannot be purchased，How to carry out evaluation work。

 

  Answer: According to the "General Administration of the General Administration on Implementing the Evaluation of the Evaluation of the Quality and Consistency of the Makeup Drugs and the Consistency of the Consistent Effects of the State Council;，The company cannot find it and cannot determine the reference preparation，Performing clinical effectiveness tests from drug manufacturers。

 

  4、Time node problem: determine the reference preparation directory as soon as possible、Selection catalog release time for exemption varieties。

 

  Answer: There is a scientific basis for the selection and determination of the stake betting appMy stake betting appreference preparation。Determination of all reference preparations，Whether it is through the corporate filing、Recommended by the Chinese Inspection Institute and Industry Association，Still declaration，All need to be announced by the Expert Committee for review。Clear one announced one，Summarize in time after reaching a certain number。

 

  Even drugs with the same main component，Use different prescriptions、The quality characteristics of the production production may not be consistent，There may be differences in the efficacy of the body。If only the API's BCS classification is exempted from all the drug preparations，There may be risks of biological incompetence。Therefore, the exemption list will be based on an enterprise application，Expert review，Published after review of the General Administration。

 

  5、Method of Historical Problem Processing Method: For some modified dosage types、Change salt、How to carry out consistency evaluation work such as changing specifications and other historical issues。

 

  Answer: The General Administration has published "General considerations of the Evaluation of the Quality and Effect Evaluation of Make Drugs" on the website of the General Administration、"Evaluation of the Evaluation of Modified Dalogs (General Oral Oral Solid Preparation) in the Evaluation of the Evaluation of the Evaluation of the Make Drugs (General Oral Oral Solid Preparations) and the Evaluation of Salt Pharmaceuticals in the Evaluation of the Consistent Evaluation of the Effect of the Make Drugs" draft)，After the formal document is formed, it can be evaluated according to the requirements in the file。

 

  6、Whether the generic drugs approved by the newly registered classification and approved by the newly registered classification application approved whether the imitation drugs were approved by the listing were regarded as a consistency evaluation。

 

  Answer: According to the provisions of the General Administration of 2015 No. 230，The imitation drugs declared and approved after the implementation of the new registration classification will be accepted and approved in accordance with the principles of the quality and efficacy of the original drug。Imitation drugs that are accepted before the implementation of the new registration classification and approved after implementation，If the company chooses to conduct review and approval in accordance with the original regulations，The need for quality and Stake Sports BettingStake Sports Bettingcurative effects in accordance with Guofa [2015] No. 44 documents within 3 years in the drug approval of the drug。

 

  Seven、289 varieties other than varieties of basis catalog，Acceptance of the corresponding consistency evaluation work、Review inspection、Review and other working procedures need to be clear procedures and requirements。

 

  Answer: The consistency evaluation work of the variety other than the variety other than the varieties of the basis catalog、Review and other working procedures and requirements should be the same as the 289 -based pharmaceutical catalog，Review and inspection unit shall be determined by the Consistency Evaluation Office of the General Administration。

 

  eight、At present, the principle of technical guidance needs to complete pharmacy research (including quality research and methodology verification)，can be submitted to the BE filing application，If be does not pass in actual work，The prescription process needs to be adjusted，Pharmaceutical research may need to be carried out。Can it further optimize the content of pharmaceutical research requirements that fill in the information during the record?

 

  Answer: The consistency evaluation of generic drugs has been established.，Start online trial operation，Please fill in the report of the operation of the BE filing platform。

 

  Nine、Can the statistical data of the consistency evaluation product of the national production enterprise in time，It is convenient for enterprises to understand the progress of the evaluation of the evaluation work products. Other enterprises participate，Number of varieties that have not been evaluated，Easy to promote the evaluation work together。

 

  Answer: The General Administration has organized the provincial bureaus to conduct a bottom -up investigation on the consistency evaluation work of the 289 catalog variety，After analysis of the corresponding information，Will open the Internet for the overall situation。

 

  Ten、During the consistency evaluation process，What procedures are approved to include drug characteristics from the corresponding quality standards in accordance with the corresponding quality standards? It is a supplementary application for changes in the associated application standards，Still directly reviewed and approved in the conclusion of consistency evaluation，Issuing new quality standards。

 

  Answer: The characteristic dissolution curve can be included in the enterprise Stake Sports Bettingstake betting appinternal control standard，The basis for monitoring the quality of the product。If it involves changes in national drug standards，It can be proposed to the Pharmacopoeia Committee，Trial of experts from the Pharmacopoeia Committee。

 

  eleven、Insufficient kinetic energy of the clinical trial institution to carry out biological equivalent tests，Biological equivalent test agencies are tight，Urgently needs to be solved。

 

  Answer: The General Administration is together with relevant departments to study biological equivalent test institutions management.。At the same time，Accelerate the on -site inspection of the qualification identification of the new application drug clinical trial agency，Priority to the new drug clinical trial institution for the demand for imitation drug biological equivalent tests to apply for on -site examination。

 

  Twelve、，At the same time of submitting relevant research materials in accordance with the Annex 4 of the Administrative Measures for the Registration of Drugs，Is it necessary。

 

  Answer: According to the "General Administration of the General Administration of Evaluation of the Quality and Consistent Evaluation Work Procedures for the Launch of the Quality and efficacy (2016 No. 105)" and the "General Administration on the release of the quality and efficacy of the quality and efficacy assessment of the quality and efficacy of chemical drugs. Requirement (No. 120, 2016) requirements (trial) "Requirements，Submit the application information at one time。

 

  Thirteen、varieties that give up the original enterprise，Whether it can simplify technology transfer to other companies，Submit consistency evaluation information from the receiver。

 

  Answer: The technical transfer of drug varieties shall be carried out in accordance with the "Regulations on the Management Regulations on the Registration of Drug Technology Transfer" issued by the State Administration。

 

  14、Non -pilot provincial and municipal enterprises after passing consistency，Can you become a holder。

 

  Answer: After the drug listing license holder system pilot area passes the consistency evaluation，Enterprises can become holders。Pilot regions need to be considered after the "Drug Management Law" is revised。

 

  Fifteenth, the number of training venues should increase, covering all areas.

 

  Answer: According to the training plan of the General Administration, many training has been successfully completed，I received a better effect，In -depth situation will My stake betting appStake Sports Bettingbe carried out according to work in the future，Continue to strengthen the training and services of enterprises。