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Active Pharmaceutical Ingredient

Drug Master File (DMF)

  • Last updated：2025-02-08
  • Count Views：4335

To improve the quality of Active Pharmaceutical Ingredients (API) of drugs, the Ministry of Health and Welfare announced the Drug Master File (DMF) Technical Dossier Checklist and the Notice for DMF Application on September 30, 2009 for industry to follow. 
The subsequent content will provide an overview of the process for applying to a DMF application. For the latest announcements, please visit the website of Pharmaceutical Regulations in Taiwan.

  • Documents required for application submission:
  • Information to Include in the Application Letter:
    • type of application: Indicate the type of application according to the API registration and DMF RTF checklist.
    • The name of the drug substance, the manufacturer and the site address.
    • The statement and the tracking number of the package: If the closed (or restricted) part will be submitted directly by the drug substance manufacturer.
  • When applying for a Drug Master File (DMF), please prepare 2 copies of electronic data discs in accordance with the "CTD format" announced by the Taiwan Food and Drug Administration(TFDA) of the Ministry of Health and Welfare, and submit primarily in PDF text format.
  • Contact Information:
    Type Recipient Address
    New Application/Appeal TFDA National Biotechnology Research Park Building F
    (Address：No.99, Ln. 130, Sec. 1, Academia Rd., Nangang Dist.,Taipei City 115, Taiwan.R.O.C.)
    Applicant’s response/Extension request CDE(Original) The Center for Drug Evaluation(CDE)
    (Address: 3F No. 465,Sec. 6,Zhongxiao E. Rd., Taipei 11557, Taiwan.R.O.C.)
    TFDA(Copy) National Biotechnology Research Park Building F
    (Address：No.99, Ln. 130, Sec. 1, Academia Rd., Nangang Dist., Taipei City 115,Taiwan.R.O.C.)
  • The submission information for the technical data Closed Part (Restricted Part) provided by the foreign API manufacturer is as follows. Please also attach a copy of the draft application letter from the domestic applicant.
    Recipient CDE API Team (with TFDA Case Number)
    Address 3F., No.465, Sec.6, Zhongxiao E. Rd., Taipei 11557, Taiwan.R.O.C.
    Telephone number 886-02-8170-6000 #512
  • Flowchart for the Drug Master File (DMF) application and Review:

    Note:

    • If the applicant is not able to meet the deadline, a written statement should be submitted to support the application of an extension. The extended deadline is one month after the expiry date of the original correction period. Only one extension will be allowed.
    • If there are any questions regarding the content of the official letter, applicants can contact the project manager (PM) or apply for Review Related Consultation (RRC).
    • For case review status, please visit the TFDA website > Drugs > Case review status.
  • Consultation Services
    The CDE has extensive knowledge of domestic and international regulations and years of review experience. We provide diverse regulatory consultation services for industry and research departments at various stages, from drug development to market entry. We welcome all applicants to utilize these services to prepare regulatory-compliant submission documents. For application details, please see Consultation Services.

For the review fees, please refer to Standards of Review Fees for the Registration of Western Medicines.

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