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Regulations

FAQ

Clinical Trial and Bridging Study

  • Q41

    Regarding the regulations on serious adverse events (SAEs) occurred during the course of clinical trials, the trial sponsor shall notify other trial institutions of this SAE as soon as possible. Do any laws or regulations of Taiwan have set a time limit for such notification?

    No requirement of the Regulations for Good Clinical Practice (GCP) has specified a time limit for notification of other trial institutions by the trial sponsor. According to Article 106 of the Regulations for Good Clinical Practice (GCP): The investigator shall immediately report any serious adverse events to the sponsor, and shall provide detailed, written reports as soon as possible. The sponsor shall report any suspected unexpected serious adverse reactions that are fatal or life-threatening to the Competent Authority or the contracted organization within 7 days after being aware of the event, and shall provide detailed written documents within 15 days after being aware of the event.

  • Q42

    Is it required to submit the development safety update report (DSUR) to the TFDA for the ongoing clinical trials?

    Depending on the case. If the TFDA requests submission of the DSUR in the IND approval letter, the clinical trial applicant shall provide said report periodically. If the TFDA does not request the DSUR, the DSUR shall be provided for IRB review and future inspection.

  • Q43

    Manufacturing of study drugs needs to meet the essence of GMP guidelines. What is the legal basis?

    See Article 64 of the Regulations for Good Clinical Practice (GCP): " The characters of the investigational product(s), including active comparator(s) and placebo should be appropriate to the stage of development of the product(s).The manufacturing, handling and storage of the investigational product(s) shall comply with the GMP. The labeling and codes should protect the blinding design ".

  • Q44

    Are there restrictions on the qualifications of the trial investigators of clinical trials?

    According to Article 4 of the Regulations on Human Trials:
    1. being a licensed physician, dentist, or traditional Chinese medicine physician with five (5) or more years of experience in clinical treatment.
    2. having received human trial-related training of more than thirty (30) hours within the past six (6) years; being the trial investigator in Human Trials of somatic cells or gene therapy with additional five (5) or more hours of relevant training.
    3.  taking medical ethics related courses for more than nine (9) hours within the past six (6) years.Those who have been subject to physician disciplinary or whose licenses have been suspended for more than one (1) month or abolished due to any violation of laws and regulations related to Human Trials shall not serve as a trial conductor.Currently, there are no regulations on the training hours for co-investigators, but said investigators shall continue to receive the relevant training.Other trial staff, such as nurses or pharmacists, shall also receive the relevant training. But no certificate is required for submission according to the IND document.

  • Q45

    How many batches’ CoAs are needed for an IND application?

    Submission of the CoA(s) of the clinical batch(s) is acceptable.

  • Q46

    Do the biologics used in clinical trials need to be manufactured in a PIC/S GMP plant?

    The CMC (chemistry, manufacturing, and control) of the testing biologics (or pharmaceutical products) using in phase I and phase II trials, should meet the essence of PIC/S GMP, whereas those using in phase III trials, meeting the requirements of PIC/S GMP is mandatory.

  • Q47

    What batch is required for stability test for an IND application?

    Submission of the stability test result of one of the clinical batch is acceptable.

  • Q48

    Do the rescue medication or concomitant medication used in clinical trials need to be re-labeled?

    Based on the GCP regulation, re-labeling of the rescue medication or concomitant medication is not necessary, however, said drugs need to be labeled as "For clinical trials only". If said drugs are purchased by the hospital, the hospital shall be informed of storage conditions, quantity, and medication records of subjects.

  • Q49

    What are the procedures for registration of clinical trials of human cellular products?

    Please proceed in accordance with the “Application Procedures and Review Guidelines for Clinical Trials of Human Cellular Products” announced by the TFDA:
    1. The sponsor shall apply to CDE (Center for Drug Evaluation) for pre-IND consultation before the actual IND submission to TFDA to ensure the data package is complete and to avoid review time delays caused by incomplete documentation.
    2. Before submission, the applicant has to complete the registration process on the Clinical Trials Network in Taiwan website and shall mail the hardcopies to the TFDA within 7 days to complete the application procedure. 
    3. The principles of applying for human cellular products are basically identical to those of pharmaceutical products. Please prepare all required documentation in accordance with the “Application Procedures and Review Guidelines for Clinical Trials of Human Cellular Products” and submit the application to the TFDA (for other general rules, please refer to “Guidance on Investigational New Drug Application” as in Q36).
    • The documents required for application of the clinical trials for human cellular products are listed in the Appendix I of the “Application Procedures and Review Guidelines for Clinical Trials of Human Cellular Products”. 
    • Regarding preparations of quality controls, non-clinical studies and clinical studies of human cellular products, please refer to Chapters 3-5 and Appendix 15 of the “Application Procedures and Review Guidelines for Clinical Trials of Human Cellular Products” .
    • Laboratory operation shall comply with the relevant provisions of the "Regulations Governing Management of Infectious Biological Materials”.

  • Q50

    How to check information regarding ongoing clinical trials in Taiwan?

    Please check Taiwan Clinical Trial Network website, the search keywords could be drug names or indications.
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