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Clinical Trial and Bridging Study
  • Q31

    The required documents for registration of clinical trials include the "possible indemnity for clinical trials and related documents". What documents are required? Is the letter of intent for insurance provided by applicants acceptable?

    Please follow the applicable requirements stated in Article 47 of the Regulations for Good Clinical Practice and provide the supporting document to prove such document is sufficient to demonstrate the liability of indemnity.
  • Q32

    Registration on the clinical trial information website is required when applying for registration of clinical trials. When the trial information and subject recruitment message will be published?

    The trial information and subject recruitment message will be published on the clinical trial information website within 20 days after implementation of the trial is approved by the TFDA.
  • Q33

    Is change of the IND applicant acceptable? How should the change be made?

    The change of IND applicant can be applied to the TFDA, in addition to the application letter, the responsible party stated in the indemnity section of the informed consent form (ICF) also needs to be changed into the new applicant. If the new applicant is a CRO, a photocopy of the pharmaceutical manufacturer license of the CRO, a photocopy of the institution license, and the power of attorney signed by the pharmaceutical company shall all be submitted. If the new applicant is a hospital, a certificate issued by the hospital needs to be submitted.
  • Q34

    How should a change of IND from academic research to registration be applied for? What documents are required?

    Regarding application for change of purpose of the IND, an application is needed and the letter shall explain the reason(s) of the change.
  • Q35

    What studies are required before submission of an IND application for an investigational drug?

    Please refer to the“Guidance of Nonclinical Safety studies of Medicinal Products” (the latest edition).
  • Q36

    Is it required to complete the reproduction toxicity studies prior to applying for phase I IND?

    In accordance with the requirements of the " Guidance of Nonclinical Safety studies of Medicinal Products " and "Clinical Trial Protocol-Guidance on Technical Documents", reproduction toxicity studies can be deferred during phase I IND and phase II IND, provided that " using precautions to prevent pregnancy in clinical trials ", also, "reproduction toxicity studies can be conducted concurrently with Phase III trials provided that to use precautions to prevent pregnancy in clinical trials. The reproduction toxicity studies need to be submitted within the NDA package (the second species is not required if the result is positive)".
  • Q37

    When applying for IND at the TFDA, can the IND application be approved directly if the IND approval certificate issued by the USFDA is available? Or is there an expedited procedure for reviewing IND applications?

    IND approval granted by the USFDA does not guarantee the IND application will be approved by the TFDA. If the clinical trial is a multinational, multicenter clinical trial that involves at least one of the A10 countries (please refer to the “Regulations for Registration of Medicinal Products”), follow the requirements specified in the "Multinational, Multicenter Clinical Trial Review Procedures" for application (Shu Shou Shi Tzu No. 0991409300 Order).
  • Q38

    Do the subjects recruited for a domestic clinical trial have to be a citizen of Taiwan? Can foreign brides or foreigners be recruited as the subjects?

    At present, no regulations have restricted the nationality of subjects. However, for subjects who are foreigners, it is necessary to ensure they fully understand the contents of the informed consent form before obtaining the informed consent from them, and according to the requirement of Article 21 of the Regulations for Good Clinical Practice, a witness shall present in all discussions relating to informed consent form (ICF) if the foreign subject cannot read Chinese. Moreover, the witness shall read all written information including the informed consent form (ICF) and ensure the person with right to give consent fully understand all the contents.

    The person with right to give consent shall personally sign and date the informed consent form (ICF). However, fingerprints may replace signatures.

    The witness shall personally sign and date the informed consent form (ICF). Trial/study-related personnel shall not be the witness.
  • Q39

    Does the TFDA require the informed consent form (ICF) of a clinical trial to be in a unified version?

    The contents of the informed consent form (ICF) have to be identical but the format of the informed consent form (ICF) may be different depending on the different requirements of the IRBs of different hospitals.
  • Q40

    The clinical trials conducted at present will test the biomarkers in the blood of subjects. Because the study design intends to keep the blood of subjects and will perform tests of other biomarkers ten years later. Are there specific regulations on such situation for the trial protocol?

    Refer to Article 12 and Article 19 of the Human Biobank Management Act for details. When planning the storage of specimens for further studies, the key is to fully inform and to ensure the rights and benefits of biological database participants. The ICF shall at least specify: the method of specimen storage (coded or anonymized), storage period (the upper limit is 20 years at present), storage site or institution, the scope of further studies of the specimens (for example, use of the specimens for studies related to a specific disease), and a specified section for participants to give written consent. 

    If the scope of future studies exceeds the scope approved initially, such application needs to be reviewed and approved by the IRB again. The data of the non-anonymized stored specimens shall be traced back to the original subject for obtaining the consent once again.