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 ".

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.

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

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.

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

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.

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”.

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

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

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.