Technical Dossier Evaluation on Drugs
Drug Substances
Drug Master File (DMF)

To improve the quality of Active Pharmaceutical Ingredients (API) of drugs, the Ministry of Health and Welfare announced the Drug Master File (DMF) Registration Technical Dossier Checklist and the Notice for DMF Application on September 30, 2009 for manufacturer to follow. Moreover, for the quality of the submission and the review process efficiency improvement, the refuse to file (RTF) action has been implemented since July 01, 2019. The following resources provide applicants with the information for registration of DMF.
Please find more information at Rules and Regulations or visit the website Pharmaceutical Regulations in Taiwan.

Ⅰ. CLASSIFICATIONS
  1. 1. Standard review
  2. 2. Abbreviated review
Ⅱ. APPLICATION FEES
  1. Please refer to Standards of Review Fees for the Registration of Western Medicines
Ⅲ. APPLICATION NOTICE
  1. 1. A cover letter should list the following information:
  2. (1) Type of application : Please indicate the type of application according to the API/ DMF RTF checklist;
  3. (2) The name of the drug substance, the manufacturer and the site address;
  4. (3) The statement and the tracking number of the package:If the closed (or restricted) part will be submitted directly by the drug substance manufacturer.
  5. 2. An applicant should submit the application via one of the following ways:
  6. (1) PDF format in CTD specifications;
  7. (2) The electronic dossier by the Taiwan Food and Drug Administration (TFDA) eCTD Builder.
  8. 3. Contact Information:
    Type Recipient Address
    New application/ Re-evaluation TFDA
    (Original 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.)
    Applicant's response / Extension request 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.)
  9. 4. If the closed part will be submitted directly to TFDA by the API manufacturer, a duplicate copy of the cover letter should be provided.
    Recipient CDE DMF Team (Please provide the TFDA case number)
    Address 3F.,No.465, Sec.6, Zhongxiao E. Rd.,Taipei 11557, Taiwan. R.O.C
    Telephone (02)8170-6000 #512
Ⅳ. DOCUMENTS FOR THE DMF APPLICATION
  1. Documents
    Cover letter*1
    Application category form*2
    DMF application RTF checklist*3
    Technical documents*4
  2. *1: Please list such information as applying for an abbreviated review on the cover letter.
  3. *2: Please list such information as applying for standard review or abbreviated review on the application category form A and form B.
  4. *3: In accordance with the announcement no. 1081404003 issued on May 20, 2019, the applicants should identify the type of DMF by the RTF checklist since July 01, 2019:
    The type of API registration RTF Checklist Announcement
    Standard review Type 1 No. 1021400426 (February 21, 2013)
    Referred to an approved DMF Type 2 No. 1081404003 (May 20, 2019)
    Abbreviated review with the official certificate Type 3 No. 1001403285 (June 21, 2011)
    Abbreviated review with CEP/COS*5 Type 4 No. 1031413543 (February 24, 2015)
  5. *4: The technical documents should include a closed part. The following parts of technical documents may be exempted for abbreviated review :
  6. - 3.2.S.2.5 Process Validation and/or Evaluation
  7. - 3.2.S.2.6 Manufacturing Process Development
  8. - 3.2.S.3.1 Elucidation of Structure and Other Characteristics
  9. - 3.2.S.4.3 Validation of Analytical Procedures
  10. - 3.2.S.5 Reference Standards or Materials
  11. - 3.2.S.6 Container Closure System
  12. - Waste Disposal and Equipment
  13. - Other documents (TSE-free, GAGP)
  14. Those documents should be retained in case of future inspection.
  15. *5: Please refer to the Announcement No. 1001403285 and No. 1031413543.
Ⅴ. NOTICE FOR A DMF APPROVAL LETTER
  1. 1. For the DMF post-approval changes, an applicant shall submit an application in accordance with Article 49-1 and Appendix 12 of the Regulations for Registration of Medicinal Products., and notify drug product manufacturers at the same time.
  2. 2. The DMF approval letter is valid for five years from the date of issue. For renew the DMF approval letter, an applicant shall submit a DMF post-approval change assessment or sign a declaration to state that the DMF has not been changed since last approval. This should be taken six months before the expiry of the DMF approval letter. The DMF application should be resubmitted if an applicant fails to apply within the validity period. A resubmitted application will be treated as a new application.
Ⅵ. THE REVIEW PROCESS

  1. 1. An applicant may request a one-month extension if they are unable to respond to the deficiency letter within two months of the issuance date. The applicant should request in writing an extension before the requested response date. Please note the time extension only can be requested only once.
  2. 2. 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.
  3. 3. 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
Ⅶ. FAQ