1. Does the range of pilot drugs include raw materials?

 

  The range of pilot drugs includes the corresponding category or situation of the raw medicine。

 

  2. Does the range of pilot drugs need to be satisfied at the same time?

 

  No need，Drug varieties satisfy one of the pilot drug scope & rdquo;。

 

  3、Is the treatment of biological products 2 single cloning antibodies apply to participate in the pilot?

 

  If the medicine it is planned to be declared is a new medicine，Considering it according to the treatment of biological products 1、Category 7 R & D declaration; if the medicines are planned to be declared, there are already listed varieties in China，Considering the research and development declaration of similar drugs。

 

  4、Can the applicant submit a registration application for different drug varieties in different pilot provinces (municipalities)?

 

  stake online sports bettingPilot work implements territorial management for applicants (holders)，During the pilot work, applicants can only choose one pilot province to submit applications。

 

  5、Can foreign research and development institutions established in China become applicants?

 

  Pharmaceutical research and development institutions that are established in accordance with the law in the pilot administrative area and can be responsible independently can become applicants。

 

  6、Can foreign scientific researchers holding the Foreigner Permanent Residence Certificate and working in China become applicants?

 

  No.

 

  7、Is the applicant (holder) for multiple subjects (that is, joint declaration)?

 

  Pilot work period，Listing license applicant and holder in principle are only one subject。

 

  eight、In the "Pilot Plan", & ldquo; Pharmaceutical manufacturers in the pilot administrative area refer to the relevant provisions of the holders in this plan to implement & rdquo; how to understand? Can pharmaceutical manufacturers apply for pilot work?

 

  Pharmaceutical manufacturers in the pilot administrative area can apply for a pilot work。

 

  Nine、Drug production enterprises as holders，Do you need to have the scope of production permits corresponding to the variety held?

 

  No need。If it is produced by himself，Need to have the corresponding qualifications。

 

  10、Pilot work How to request the certification certificate of the "Quality Management of Drug Production" of the entrusted production enterprise?

 

  For the drug medicine、Biological Products，When declaration，Related trustee manufacturers shall be prepared in the workshop that complies with the "Specification of Drug Production Quality Management" (hereinafter referred to as GMP)，The preparation stake online sports bettingprocess shall strictly implement the GMP requirements; after the listing permit application is approved，Related trustee manufacturers can apply for GMP certification with the approval document of the pilot variety; after passing the certification，Fang can be produced、Sales related products; cancellation of commission relationship，and the drug GMP certificate or production scope of the corresponding species is the only related to the variety，The provincial drug supervision and management department where the trustee is located will be recovered or reduced by the corresponding GMP certificate or production scope of the variety。

 

  For the removal medicine、Pilot drug varieties other than biological products，When declaration，Related trustee manufacturers shall hold GMP certifications containing the corresponding dosage range。

 

  eleven、Can the holder entrust multiple trusted manufacturers to produce pilot drugs at the same time?

 

  Yes，But the holder should submit relevant technical verification information，To ensure the consistency of the quality and efficacy of drugs in different places。

 

  Twelve、Can the applicant (holder) entrust third -party subjects to carry out drug quality supervision work?

 

  Yes，But the relevant commission cannot avoid the obligation and responsibility that the applicant (holder) should perform。

 

  Thirteen、Some medicines that have been approved before the implementation of the pilot plan，Drugs that are evaluated by the consistency of quality and efficacy，How do applicants apply for a pilot?

 

  Drugs that are evaluated by the consistency of quality and efficacy，Meeting the requirements of the stake online sports bettingpilot work，Its pharmaceutical manufacturers can apply for the holder。

 

  14、Variety of "Approval of Drug Clinical Test" has been obtained，belonging to the range of pilot drugs，Can I apply for a change (increase) clinical trial approval applicant?

 

  Meeting the requirements of the pilot work，You can apply for，and submit the termination agreement signed by the relevant subject or cooperation contract。Given the current chemical generic drug biological equivalent test (BE test) has been implemented in the filing management system，Therefore, the corresponding clinical trial approval of the 3rd and 6th category of the original chemical drugs is no longer conducting the approval of related changes。

 

  fifteen、The main body of the pilot work is the provincial drug supervision and management department or the Food and Drug Administration?

 

  The provincial pharmaceutical supervision and management department where the applicant is located has carried out acceptance work and put forward the review opinions，Report Food and Drug Administration for review and approval。

 

  16、Application of the raw materials and preparations declared by related declarations，The applicant intends to apply for the pilot，Do you need to apply at the same time?

 

  No need。Applicants can choose to propose an application for materials or preparations to participate in the pilot work.。

 

  17、Holding people for drug production enterprises，Can it be produced by itself，Application to commission the pilot pharmaceutical variety of commissioned production enterprises?

 

  Yes，But the holder should submit relevant technical verification information，To ensure the consistency of the quality and efficacy of drugs in different places。