FAQ
Drugs

What documents should be submitted for a DMF application?

刊登日期:2020-07-22  |  點閱次數 : 4037 次 

Applicants should select one of the review processes for DMF submission as follows:

  1. 1. Applied for a standard review:
    1. (1)Cover letter (listing the name of a drug substance, the manufacturer and the site address)
    2. (2)Application category form
    3. (3)API Registration and DMF Application Refuse to File (RTF) Checklist 1
    4. (4)Drug Master File Registration Technical Dossier Checklist (meeting the requirements listed in the announcement No. 1021401257 issued on February 21, 2013)
    5. (5)Technical Dossier (including an open Part and a closed Part)
    6. (6)If the applicant holds the API license with a DMF number, or the DMF number of a drug substance is on the “DMF approved list” announced by the TFDA, the item (3), (4) and (5) can be exempted
  2. 2. Applied for a DMF submission referred to an approved DMF:
    1. (1)Cover letter (listing the name of a drug substance, the manufacturer, the site address and the approved DMF number previously)
    2. (2)Application category form
    3. (3)API Registration and DMF Application Refuse to File (RTF) Checklist 2
    4. (4)Letter of authorization
    5. (5)A declaration of no manufacturing process changes or process changes approval letters from the drug substance manufacturer provided in the application data
    6. (6)Technical Dossier (including an open Part)
  3. 3. Applied for an abbreviated review with the official certificate:
    1. (1)Cover letter (listing the name of a drug substance, the manufacturer, the site address and note that applied for an abbreviated review)
    2. (2)Application category form (Please note that an abbreviated review cannot be transferred to a standard review after submission)
    3. (3)API Registration and DMF Application Refuse to File (RTF) Checklist 3
    4. (4)Official certificates: authenticating the drug substance that has been approved by regulatory agencies such as the US FDA, EDQM, EMA, PMDA or regulatory agencies of the A10 countries(Germany, US, UK, France, Japan, Switzerland, Canada, Australia, Belgium, and Sweden) or the drug substance that has been used in marketed medicinal products in one of the A10 countries.
    5. (5)According to the announcement no. 1001403285 entitled “Submitting Drug Master File Technical Documents for Abridged Review” issued on June 21, 2011, the documentary requirements for technical dossier are as follows:
      1. (a)Information on starting materials (including sources, specifications, certificates of analysis, etc.)
      2. (b)Information on synthesis steps and manufacturing flow diagrams. (with descriptions for process step yields and material input amounts)
      3. (c)Information on organic solvents, catalysts, and reagents used in the synthesis
      4. (d)Information on the drug substance (final product), intermediate specifications, analytical procedures (method references may be provided), and certificates of analyses
      5. (e)Information on stability testing conditions and stability data
  4. 4. Applied for an abbreviated review with a Certificate of suitability of European Pharmacopoeia monographs (CEP/COS):
    1. (1)Not applicable for drug substances are sterile, biological, fermented and plant-derived material
    2. (2)Cover letter (listing the name of a drug substance, manufacturer, site address and note that applied for an abbreviated review with CEP/COS)
    3. (3)Application category form (Please note that an abbreviated review with CEP/COS cannot be transferred to a standard review after submission)
    4. (4)API Registration and DMF Application Refuse to File (RTF) Checklist 4
    5. (5)According to the announcement no. 1031413543 entitled “Submitting Technical Documents with EDQM CEP/COS” issued on February 24, 2015, the documentary requirements for technical dossier are as follows:
      1. (a)Letter of authorization (to authorize the TFDA to refer CEP/COS technical documents)
      2. (b)A declaration that there has been no change to the approved manufacturing process
      3. (c)Certificates of analysis (for at least three batches)
      4. (d)Current synthesis steps or manufacturing processes approved by EDQM

(中文版)


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