Technical Dossier Evaluation on Drugs
Drug Substances
Application for Drug Registration of Active Pharmaceutical Ingredients (API)

According to Article 6 and Article 39 of the Pharmaceutical Affairs Act, the manufacturing and importation of the drugs which are used in preparing preparations shall be filed with the central competent health authority (Taiwan Food and Drug Administration, TFDA) for registration and market approval. No manufacturing or importation of such drugs shall be allowed until a drug permit license is approved and issued. According to Article 42 of the Regulations for Registration of Medicinal Products, the API submission shall be in accordance with its Appendix 8 and 9. To improve the quality of the submission and the review process efficiency, the refuse to file (RTF) action has been implemented since July 01, 2019. The following resources provide applicants with the information for registration of API.

Please find more information at Rules and Regulations or visit the website Pharmaceutical Regulations in Taiwan

Ⅰ. CLASSIFICATIONS
  1. 1. Domestic API
  2. (1) Standard Review
  3. (2) Abbreviated Review
  4. 2. Foreign API
  5. (1) Standard Review
  6. (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 : Indicate the type of application according to the API registration and DMF application 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 TFDA eCTD Builder.
  8. 3. 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.)
    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 API Team (Please provide the TFDA case number)
    Address 3F., No. 465, Sec. 6, Zhongxiao E. Rd., Nangang Dist., Taipei 11557, Taiwan (R.O.C.)
    Telephone (02)8170-6000 #512
IV. DOCUMENTS FOR THE API REGISTRATION
  1. Documents Domestic API Foreign API
    Application fees
    Cover letter*1
    Submission type form*2
    Application form (original copy and duplicate copy)
    Assurance statement (A and B)
    Label and package insert sticking form (two copies)
    License sticking form (one copy)
    Authorization letter X
    API registration and DMF application RTF checklist*3
    Technical documents*4
    Photocopy of the API GMP compliance certificate dated within the past 2 years
    Official certificates of the A10 countries*5 Δ Δ
  2. ○: submission required; X: not required; Δ: on a case-by-case basis
  3. *1: Please list such information as applying for an abbreviated review or a reference letter of DMF on the cover letter.
  4. *2: Please list such information as applying for standard review or abbreviated review on the application category form A and form B
  5. *3: The applicants should tick the RTF checklist according by the type of API registration
    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  (June 21, 2011)
    Abbreviated review with CEP/COS*5 Type 4  (February 24, 2015)
  6. *4: Technical document requirements for the API registration are the same as DMF. The documents should include a closed part. The following parts of technical documents may be exempted for abbreviated review :
  7. - 3.2.S.2.5 Process Validation and/or Evaluation
  8. - 3.2.S.2.6 Manufacturing Process Development
  9. - 3.2.S.3.1 Elucidation of Structure and Other Characteristics
  10. - 3.2.S.4.3 Validation of Analytical Procedures
  11. - 3.2.S.5 Reference Standards or Materials
  12. - 3.2.S.6 Container Closure System
  13. - Waste Disposal and Equipment
  14. - Other documents (TSE-free, GAGP)
  15. Those documents should be retained in case of future inspection.
  16. *5: Please refer to the Announcement No. 1001403285 and No. 1031413543.
Ⅴ. 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
VI. FAQ