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Regulations

FAQ

Clinical Trial and Bridging Study

  • Q51

    The applications for registration of clinical trials also need to be approved by the TFDA and hospital IRB. Can the IND application be submitted to the TFDA before approval is granted by the hospital IRB?

    The clinical trial applicants can submit the application for parallel review by the two units mentioned above.

  • Q52

    If the IND application is approved by the TFDA but the approval letter is issued under the provisions of a proviso. Do these items need to be corrected? Is submission of an amendment required?

    There are two types of proviso for clinical trials that have been approved by the TFDA for implementation but the approval is under the provisions of a proviso, description and suggestion, the applicants that receive a "description" shall proceed in accordance with the provisions of the proviso, whereas the applicants that receive a "suggestion" do not need to follow the comments which are given merely from the perspective of laws and science. If applicants have any objections to the proviso, a letter shall be issued to the TFDA to explain the reason(s) and facilitate communication. 

    If the TFDA letter approves implementation of a trial and the version of the trial protocol as well as the informed consent form (ICF), the provisions of the proviso will not affect implementation of the trial and the applicant can start implementation of the trial. If the TFDA letter does not approve the version of the trial protocol and the informed consent form (ICF), the trial protocol and ICF shall be corrected, amended, or explained in accordance with the provisions of the proviso before re-submission of the IND application to the TFDA.
     

  • Q53

    For ongoing clinical trials, is it required to submit an amendment application to the TFDA for change of the placebo batch number?

    Submission of an IND amendment is not required. Issue a letter to notify the TFDA is acceptable.

  • Q54

    For ongoing clinical trials, what else information is required in addition to the reports of CoA and shelf life of the drug if an amendment application for extension of the effective period of the study drug for additional 6 months is anticipated? After completion of the amendment application, can the effective period of the study drug that has been delivered to the trial institution(s) be changed to 24 months by re-labeling?

    To extend the effective period of a study drug, submission of an amendment application is required. The submitted information shall include the stability test results of the extension.

    In addition, the labeling of the study drug may be corrected by re-labeling, however, a complete and rigorous relabeling SOP is required. Moreover, the re-labeling operation shall be performed by professional staff who have received re-labeling-related training, in order to prevent inclusion of such operation in the material weakness list during future GCP inspection. 
     

  • Q55

    Regarding the Subparagraph 3 of Paragraph 2 of Article 38-2 of the Regulations for Registration of Medicinal Products, "For a multination, multicenter, phase III clinical trial, 80% of the enrolled subjects have to be Taiwanese or more than 10% of the total number of subjects need to be Taiwanese", what is the basis for determination of the number of subjects in a clinical trial?

    The provisions of the Guidelines for the Registration of Medicinal Products only specify the number of subjects that can be assessed "in principle" and the final number of subjects needs to be determined on a case-by-case basis.

  • Q56

    Can the application for phase II trial be submitted prior to completion of the closure report of the phase I trial or such application can only be submitted after data analysis is completed for the phase I trial?

    The TFDA does not have regulations on when to submit the application for phase II trial and submission of such application prior to completion of the closure report of phase I trial is acceptable. However, if the design of the phase II trial is based on the preliminary results of phase I trial, the summary report of the preliminary results of phase I trial shall be included in the application for phase II trial or a brief description of the relevant data of phase I trial shall be included in the Investigator Brochure.

  • Q57

    For investigational drugs in clinical trials, is annual DSUR submission to National ADR Reporting Center mandatory according to the public notice (Shu Shou Shi Zi No. 1021401633) announced by the TFDA designating National ADR reporting center as the affiliated organization for handling the ADR system?

    For investigational drug in clinical trials, sponsors and hospitals need to report AE/SAE/SUSAR under GCP regulation, while submission of the DSUR is not required.

  • Q58

    An ongoing clinical trial is about to be completed and the enrolled patients are scheduled to take part in different extension studies. Is it required to submit another IND application? Or the notification of the extension studies can be sent to the TFDA directly?

    If the extension study is planned to be part of the main study, application of protocol amendment is required. If patients from multiple trials are going to be enrolled in the same extension study, a separate IND application shall be submitted to the TFDA.

  • Q59

    Are there laws or regulations for recycling investigational drugs in clinical trials?

    Recycling investigational drugs shall be in accordance with the standard procedures delineated in the trial protocol and set by the sponsor, and the competent authority only requires storage of the study drugs, control of the quantity of the study drugs, and preservation of the relevant records.

  • Q60

    Does the TFDA have specific regulations on the format of the clinical trial reports?

    Please refer to the “Structure and Content of Clinical Study Reports”. Regarding multinational, multicenter clinical trials, subgroup analysis for efficacy and safety results shall be performed on Taiwanese patients.
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