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  • Common FAQ
  • What Is The Qualification Requirement For Testing Labs For Non-clinical Research?

    Initial registration submission dossier, Chapter 3 is for the Non-Clinical Research Material. In this chapter, the test report we submitted does not have to be performed or generated by the manufacturer itself. The manufacturer can engage an external lab to complete the test. There is no specific requirements for the qualification of the external lab. 

    Examples of test: virological test, immunological test.

    READ MORE >

  • How To Define The “6-month” For Submission Of The Renewal

    The renewal submission must be submitted 6 month prior to the certificate expiration date. 

    If the submission dossier is incomplete or the submission is not acceptable because of unapproved compulsory standard upgrade, the registrant will receive a pre-submission supplemental notice. Even though the submission is not officially accepted, the 6-month renewal deadline has been made.

    READ MORE >

  • What Are The Requirements For Storage Location Of Information Backup And Filing?

    If the filing type is provided outbound, fill the website if network transmission is selected as the method of external provision; fill in the address if physical storage medium is selected; fill the database name if the filing type is open use.

    READ MORE >

  • Is It Necessary To Do Information Back Up And Filing By Using The Published Data Of Human Genetic Resources?

    No need to do information backup and filing.

    READ MORE >

  • An International Cooperative Clinical Study Is Divided Into Two Applications: Registration And Exploratory. Does It Need To Apply For Backup And Filing Separately For The Outbound Data Information?

    Information backup and filing shall be conducted separately.

    READ MORE >

  • If The Project Data Is Submitted To Other National Administrative Departments In Stages, Is It Necessary To Apply Information Back Up And Filing?

    Providing human genetic resources information to foreign entities other than the cooperative parties requires information backup and filing.

    READ MORE >

  • If There Are Different Receivers, Does The Information Need To Be Backed Up And Filed Separately?

    The outbound data information shall be backed up at one time. If it needs to be provided to multiple parties, it shall be filed for multiple times according to different receivers.

    READ MORE >

  • How Should The Real-time Outbound Data Information Be Backed Up And Filed?

    If genetic data information is involved, data backup shall be carried out for the type of outbound data information, total number of cases, unit / specification, etc., and the data volume of the whole project shall be estimated for data filing. After the filing is approved, data backup shall be carried out regularly. If the actual amount of backed up data is expected to exceed the amount of filed data, filing change shall be carried out; If gene data information is not involved, information backup and filing are not required.

    READ MORE >

  • When Should Do Information Back Up And Filing In Case Of The Published Articles That Involve The Open Use Of Human Genetic Resources Information?

    Before data information shared outside of China.

    READ MORE >

  • Can The Foreign Entity Be The Applicant For Information Backup And Filing?

    No, it should be applied by the Chinese data information owner.

    READ MORE >

  • Can The End Time Of External Provision Of Information Backup And Filing Be Later Than The Deadline Of International Cooperation?

    Yes.

    READ MORE >

  • For An International Cooperative Clinical Trial, If The Summary Report Or Other Trial Data Provided To Other Entities (Chinese Entities) Other Than The Cooperative Parties, Whether Is It Open For Use, Or Need Do Information Backup And Filing?

    It is not the providing to overseas nor open for use, so there is no need for information backup and filing.

    READ MORE >

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