According to the "Opinions of the State Council on the Approval System for Reforming the Reform of the Medical Devices and Medical Devices" (Guofa [2015] No. 44)、"Notice of the General Office of the State Council on the Opinions of the Evaluation Opinions on the Evaluation of the Quality and Consistent Effects of the Make Drug" (National Office [2016] No. 8)、"Administrative Measures for Drug Registration" (Order of the State Food and Drug Administration Order No. 28, 2007)、"Administrative Measures for Imports of Drugs" (National Food and Drug Administration、Order of the General Administration of Customs No. 4) and "Announcement on Several Policies on Drug Registration Review Approval" (National Food and Drug Administration Announcement No. 230, 2015)，Contrastable drugs required for eligible drug development，It can be imported at one time。The relevant matters are announced as follows:

 

  1. Scope of application

 

  Drug research and development institutions or pharmaceutical manufacturers during the research process，For medicines that have been listed abroad but have not been listed in China，It is intended to be used for the following uses，Apply for one -time imports:

 

  (1) Studies for the purpose stake sports betting appof Stake Sports Bettingregistering for drugs in China;

 

  (2) Studies for the purpose of evaluation of the quality of generic drugs and the consistency of the efficacy of generic drugs。

 

  2. Application procedure

 

  The State Food and Drug Administration commissioned the provincial food and drug supervision and management department to take responsibility for the acceptance of the control of the controlled drugs required during the development process、Examination and approval。The specific application procedure is as follows:

 

  (1)，Applicants prepare information in accordance with the information requirements，Fill in the "Application Form for Imported Drugs" (Annex 1)，Small to the provincial food and drug supervision and management department of the local area to apply for a one -time import application for control drugs。

 

  R & D institutions or manufacturers can also entrust an agency as an applicant to submit the corresponding application。

 

  (2) The provincial food and drug supervision and management departments shall conduct formal review on 5 working days，Meeting the requirements，Quote to accept，and issue a notice of acceptance。

 

  (3) After acceptance，Provincial food and drug supervision and administration departments will review the one -time import application within 20 working days，Meeting the requirements，Send to "Imported Drug Approval" (Annex 2);，Send to the "Notice of Approval Opinions"。

 

  "Imported Drug Application" is valid for 12 months，Batch should indicate the specific use of the imported controlled drugs，Clarify relevant responsibility requirements at the same time。Copy to the State Food and Drug Administration、Provincial Food and Drug Supervision Department, where the clearance port is located。belonging to the commissioned，Copy to the provincial food and drug supervision department of the commissioner's location at the same time。

 

  3, the requirements for the application information

 

  (1) Copy document legitimate registration document of the applicant's institution (such as business license、Organization code certificate, etc.)。belonging to the commission application，A copy of the legal registration Stake Sports Bettingstake online sports bettingdocument of the client must be provided with the client's legal registration document。

 

  (2) Application report。The content should include: domestic and overseas listing of importing control drugs、It is planned to apply for the source of import control drugs、Specific use、quantity、Port for using plans and imported drugs。The applicant's written commitment that the imported drugs are not used for listing sales and application purposes。

 

  The above application report and commitment must be stamped with the applicant's seal，The applicant belongs to the commission agent，The above material provides the above material。

 

  (3) The foreign approved listing materials for the import controlled drugs (the approval document issued by the state pharmaceutical regulatory department of the listing of the state drug supervision department、Pharmaceutical manual listed overseas or public information on the website of the National Drug Administration of the State Drugs)。

 

  (4) The applicant belongs to the commission agent，Provide a review opinions issued by the provincial food and drug supervision department where the commissioner R & D agency or the manufacturer is located (attachment 3)。

 

  4. Import filing requirements

 

  The controlled drugs that are planned to be imported should be imported from the drug import ports stated from the "Approval of the Imported Drugs"。Import filing shall be handled in accordance with the following procedures:

 

  (1) The applicant submits an application to the Port Food and Drug Administration to apply for the "Import Customs Customs Form"，and provide the following information at the same time:

 

  1. The imported drug approval of the imported drugs;

 

  2. A copy of the legal registration document of the applicant's institution (such as business license、Organization code certificate, etc.)。belonging to the commission application，A copy of the legal registration Stake Sports Bettingstake online sports bettingdocument of the client must be provided with the client's legal registration document;

 

  3. Certificate of origin of the origin;

 

  4. Copy goods contract;

 

  5. Packing order, reciprocating form and freight invoices;

 

  6. Drug manual and packaging、Tag patterns (except for the middle body of the raw medicine and preparation);

 

  7. Imported medicines to other countries or regions，Need to submit all the purchase contracts from the origin of the origin to the exit、Packing My stake betting appbill、Make -up form and freight invoice。

 

  stake betting appThe above -mentioned copies shall be stamped with the applicant's official seal.

 

  (2) Port Food and Drug Administration shall handle the import filing of control drugs in accordance with the relevant provisions of the "Administrative Measures for the Import of Drugs"。In the censorship，Strengthen the document for the origin of the origin、Review of documents such as purchasing contracts and invoices，Confirm that the real place of imported controlled drugs imported。

 

  (3) Portal Food and Drug Administration reviews all information after all information，Quote import filing，Effects "Import Drug Clearance Flies"。

 

  (4) Study a one -time import application for the control drug，Can not be required to perform port inspection。

 

  5. Other requirements

 

  (1) The applicant is responsible，The quality and safety of the controlled drug imported by the imported control、Use management and risk prevention and control and processing in the process，Use strictly in accordance with the approved use。

 

  The applicant belongs to the commission agent，The client assumes the above responsibilities and obligations。

 

  (2) Control medicine for clinical trials，After the import is imported, the qualified party can be used for clinical trials。Applicants can test themselves，You can also entrust the drug inspection institute to conduct commission inspection。Inspection standards can be selected as the following: (1) Quality standards of manufacturers; (2) the standards collected in the current version of the "Pharmacopoeia of the People's Republic of China";，and meet the general requirements of the current version of the Pharmacopoeia of the People's Republic of China。

 

  During the clinical research process and after the research is over，The applicant shall report to the provincial food and drug supervision and management department of the local provincial food and drug supervision and management department in time。

 

  The applicant belongs to the commission agent，The client completes the above work。

 

  (3) The provincial food and drug supervision and management departments are responsible，The use of imported control drugs in its drug research should strengthen supervision and verification，Especially the controlled medicine for clinical trials，Keep a key supervision，Safety stake betting appof clinical medication。

 

  My stake betting app(4) belonging to anesthesia drugs、Psychiatric drugs、Comparison drugs for biological products for clinical trials，Not applicable this announcement。