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Regulations

FAQ

Clinical Trial and Bridging Study

  • Q21

    When is the proper time to apply a BSE (Bridging Study Evaluation)?

    The Executive Yuan, the Department of Health Order Wei-Shu-Yao-Tzu No. 0980303366 on February 13, 2009 specified that the application for evaluation of bridging studies shall be submitted prior to or concurrently with the new drug application for registration of a new chemical entity.

  • Q22

    What kinds of new drugs need to apply for evaluation of bridging studies? What are the required documents?

    The new drugs indicated in Article 7 of the Pharmaceutical Affairs Act refer to drugs which are of the preparations having new compositions, new therapeutic compounds or new method of administration as verified and recognized by the central competent heath authority. The Executive Yuan, the Department of Health Order Wei-Shu-Yao-Tzu No. 0980303366 on February 13, 2009 specified that the application for evaluation of bridging studies shall be submitted prior to or concurrently with the new drug application for registration of a new chemical entity. The remaining drugs which are not new drug substances or not on the list of drugs that need to submit BSE promulgated by central health regulatory authority, in principle, do not need to apply for evaluation of bridging studies. Bridging Study Evaluation Checklist shall be completed for application of the evaluation of bridging studies and the complete clinical data package (CCDP) shall be submitted, moreover, inclusion of the data of Asians is desirable.

  • Q23

    What is the review fee rate for each clinical trial application?

    Please make the payment according to the fee rates specified in “Standards of Review Fees for the Registration of Western Medicines and Medical Devices” announced by the TFDA, Ministry of Health and Welfare.

  • Q24

    Who is qualified to submit a clinical trial application?

    According to the “Guidance on Investigational New Drug Application”, the applicant of a clinical trial shall be a licensed drug company or a CRO or a certified teaching hospital. The pharmaceutical manufacturer shall submit a photocopy of the drug company license, if the applicant is a hospital, please submit the hospital certification (i.e. the letter issued by the hospital to the TFDA). The CRO shall submit the drug company license of the CRO in addition to the power of attorney signed by the sponsor. The retained CRO shall ensure the sponsor meets the term of “pharmaceutical firms” specified in Article 14 of the Pharmaceutical Affairs Act and is granted with a pharmaceutical firm business license.

  • Q25

    How to submit a clinical trial application in Taiwan? What information shall be included?

    When submitting a clinical trial application, the applicant shall prepare relevant documents based on the “Appendix I: Information Required for Clinical Trial Application” of “Guidance on Investigational New Drug Application” and submit the application to the Joint Service Center of the TFDA, Ministry of Health and Welfare, and the recipient is: Pharmaceutical Product Division, Food and Drug Administration (No. 161-2, Kunyang Street, Nangang District, Taipei City 11561). Before submission, the applicant has to complete the registration process on Clinical Trials Network in Taiwan website. The applicant may decide whether to disclose the registered information to public if the clinical trial is for academic research purpose. (The Executive Yuan, the Department of Health Order Wei-Shu-Yao-Tzu No. 0950325965)

  • Q26

    How many copies of dossiers are required for submission of a clinical trial application at present?

    According to the provisions of the “Guidance on Investigational 
    New Drug Application”: 
    (1) If the application is submitted by hard copy, the number of hard copies required is:
    New application for a clinical trial: One original and 6 photocopies.
    Appeal for a clinical trial: One original and 6 photocopies.
    Clinical trial amendment: One original and 3 photocopies.
    New application for Bridging Study Evaluation (BSE): One original and 4 photocopies.
    (2)To facilitate processing/filing, the applicant shall also provide electronic files according to the “Electronic File Checklist for Applications”. Please refer to “Guidance on Investigational New Drug Application”, Appendix V.
     

  • Q27

    Are there restrictions on the sites that are permitted to conduct clinical trials in Taiwan?

    The sites for implementation of clinical trials shall be certified 
    teaching hospitals or medical care institutions with specific expertise and having obtained the approval of the central competent authority as specified in Article 78 of the Medical Care Act. 
     

  • Q28

    Is the indemnity associated with the clinical trial the responsibility of the CRO in Taiwan or the foreign trial sponsor if a CRO is contracted by a foreign pharmaceutical company to conduct a clinical trial?

    In order to protect the interests of the subjects of domestic clinical trials and to ensure no international lawsuits will arise from the liability of indemnity, the TFDA asks the clinical trial applicants to provide the relevant information indicated in the appendix of the Minutes of the 2014 c-IRB Government and Academic Conference (sixth): "Informed Consent Form (ICF) Checklist" and specifies that the party that is responsible for trial-associated indemnity shall be the IND applicant with a domestic pharmaceutical manufacturer license (that is, a domestic CRO company) and the content of this checklist cannot be modified. If the CRO in Taiwan signs a separate indemnity agreement with the foreign pharmaceutical company, Government will not intervene. To inquire more about issues relating to the informed consent form and indemnity, please contact with the IRB of each hospital.

  • Q29

    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.

  • Q30

    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.

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