Technical Dossier Evaluation on Drugs
Clinical Trials
Investigational New Drug (IND)

IND applications should meet the requirements set forth in the Notices for the Application of Clinical Trials announced by Taiwan Food and Drug Administration (TFDA) of the Ministry of Health and Welfare. Applicants shall register the study protocol on Clinical Trials Network in Taiwan before submission. The following resources provide applicants with the information for IND. Please find more information at Rules and Regulations or visit the website Pharmaceutical Regulations in Taiwan.

Ⅰ. APPLICANT ELIGIBILITY
  1. 1. An applicant shall be a teaching hospital qualified by the Ministry of Health and Welfare in conjunction with the Ministry of Education OR a registered pharmaceutical company.
  2. 2. The investigator(s) and trial staff shall be qualified by training and shall comply with Good Clinical Practice (GCP). The investigator(s) shall meet the qualifications specified in Article 6 of the Regulations on Human Trials.
Ⅱ. APPLICATION FEES
  1. 1. Investigational New Drug (IND): TWD 30,000.
  2. 2. IND amendments (post-approval changes): TWD 5,000.
Ⅲ. APPLICATION PROCEDURE AND SUBMISSION REQUIREMENTS
  1. 1. An applicant shall register the clinical trial on「Clinical Trials Network in Taiwan」before submitting IND application, containing the following information:
  2. (1) The name of the sponsor
  3. (2) The name(s) of the investigational product (including active ingredients, the dosage(s) and the dosage form(s))
  4. (3) The title of the study (with the protocol number)
  5. (4) The statement of the objectives and purpose of the study
  6. (5) The name(s) of the clinical research center(s)
  7. (6) The phase(s) and planned duration of the clinical trial
  8. (7) The name(s) and the phone numbers of the contact(s)
  9. (8) The criteria for inclusion and exclusion of patients and the number of subjects
  10. The submission procedure will not be completed until the hard copy and the electronic copy (CD-ROM) has been submitted to TFDA within seven days of the registration date.
  11. 2. For an IND application, an applicant shall submit a cover letter to state the general IND information including the title of the trial (with the protocol number), the name of the institution, the name of investigator(s), the category (commercial or research), etc.
  12. Please submit documentation in accordance with the requirements of "the Notices for Clinical Trial Application of Drugs" announced by TFDA and state the version number and date of each document.
Ⅳ. APPLICATION NOTICE
  1. 1. An applicant may consult with CDE before an IND submission:
  2. (1) During the R&D phase, an applicant may consult with CDE via Clinical Trial Consultation to understand IND submission requirements.
  3. (2) Before submission, an applicant may apply for IND Prior Assessment. It can assist the applicant in preparing the complete IND application and minimizing deficiencies.
  4. (3) For a human cell therapy products clinical trial: To avoid requiring a longer review time due to incomplete information, an applicant may apply for Cell pre-IND consultation to confirm the completeness before submission.
  5. 2. Number of Copies:A hard copy and an electronic copy.
  6. 3. Specifications:The hard copy should be printed on A4 paper with multiple punched holes on the left-hand side and be submitted in binders. The text on the paper should be clear and not be damaged due to binding or punching.
  7. 4. Binding and Packaging:
  8. (1) Please submit documentation in 2-ring or 3-ring binders. Documentation should be split into two or more binders if the submission is too large. It is recommended to attach a header on each binder with the drug name (Brand name / Generic name) and the name of the applicant.
  9. (2) Labels / Pagination: Please organize binders with color dividers and label with section titles on the right side of the page.
  10. (3) Please organize the documentation in order of this reference: “IND Application Submission Requirements".
  11. 5. Contact Information:
Type Recipient Address
New application/ Re-evaluation the Food and Drug Administration
(TFDA)
(A) National Biotechnology Research Park Building F
Address:Bldg. F, No.99, Ln. 130, Sec. 1, Academia Rd., Nangang Dist., Taipei City 115, Taiwan (R.O.C.)
(B) Joint Services Center
Address:No.161, Kunyang St., Nangang District, Taipei, 115-61, Taiwan (R.O.C.)
(C) The Center for Drug Evaluation (CDE)
Address:3F No.465, Sec.6, Zhongxiao E. Rd., Taipei 11557, Taiwan. R.O.C
Supplements/ Extension reques CDE
(Original copy)
The Center for Drug Evaluation (CDE)
Address:3F No.465, Sec.6, Zhongxiao E. Rd.,
Taipei 11557, Taiwan. R.O.C
TFDA
(Duplicate copy)
(A) National Biotechnology Research Park Building F
Address:Bldg. F, No.99, Ln. 130, Sec. 1, Academia Rd., Nangang Dist., Taipei City 115, Taiwan (R.O.C.)
(B) Joint Services Center
Address:No.161, Kunyang St., Nangang District,
Taipei, 115-61, Taiwan (R.O.C.)
Ⅴ. IND REVIEW PROCESS

  1. 1. Since July 1, 2019, supplements or amendments for deficiencies should be submitted not later than 14 days after the issued date of the deficiency notice and the request for an extension is not allowed. If an applicant fails to make a response within the deadline, the central health competent authority can reject the application based on the currently available information.
  2. 2. Based on the principles of risk management, if there are specific matters after the technical review, TFDA / CDE will submit the application to the Drug Advisory Committee for discussions as needed.
  3. 3. An applicant may contact the project manager or submit requests for consultations via Consultation Services on Cases under Review if they have any question about the deficiency letter.
  4. 4. The review status may be inquired through the Status of the Application or the TFDA’s website https://www.fda.gov.tw/TC/cases.aspx