Drug Master File (DMF)
I/II : Introduction/ Description:
- Drug Master File or DMF is a document prepared by a pharmaceutical manufacturer and submitted solely at its discretion to the appropriate regulatory authority in the intended drug market.
- A Drug Master File (DMF) is a submission to Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. The submission of a DMF is not required by law or FDA regulation
- The information contained in DMF may be used to support an Abbreviated New Drug Application (ANDA) , a New Drug Application (NDA), an Investigational New Drug Application (IND), another DMF, an Export Application, or amendments and supplements to any of these.
III. Types of DMF :
There are Total five types of DMF’s:
Type I : Manufacturing Site, Facilities, Operating Procedures, and Personnel
Type II DMF : Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
Type III : Packaging Material
Type IV : Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
Type V : FDA Accepted Reference Information
IV : Submission to Drug Master File :
The DMF must be in English language. Whenever a submission contains information in another language, an accurate certified English translation must also be included.
Each DMF submission should contain a transmittal letter, administrative information about the submission and specific information should be included in DMF as described in this sections.
Each page of each copy of the DMF should be dated and consecutively numbered. An updated table of contents should be included with each submission.
V: Authorization to refer to a drug master file :
DMF holder must submit in duplicate to the DMF a letter of authorization permitting FDA to reference the DMF.
The holder does not need to send a transmittal letter with its letter of authorization.
The letter of authorization should include the following:
- Date.
- Name of DMF holder.
- DMF number.
- Name of person(s) authorized to incorporate information in the DMF by reference.
- Specific product(s) covered by the DMF.
- Submission date(s) of 5, above.
- Section numbers and/or page numbers to be referenced.
- Statement of commitment that the DMF is current and that the DMF holder will comply with the statements made in it.
- Signature of authorizing official.
- Typed name and title of official authorizing reference to the DMF.
VI : Processing and reviewing policies of DMF :
An original DMF submission will be examined on receipt to determine whether it meets minimum requirements for its content and format. If the submission is administratively acceptable, FDA will acknowledge its receipt and assign it a DMF number.
If the submission is administratively incomplete or inadequate, it will be returned to submitter with a letter of explanation from the Drug Master File Staff, and it will not be assigned a DMF number.
VII: Holder Obligations with respect to dossier submission :
Any change or addition, including a change in authorization related to specific customers, should be submitted in duplicate and adequately cross referenced to previous submissions. The reference should include the date, volume, section and page numbers affected.
VIII: Major Reorganization of a Drug Master File :
A holder who plans a major reorganization of a DMF is encouraged to submit a detailed plan of the proposed changes and request its review by the Drug Master File Staff. The staff should be given sufficient time to comment and provide suggestions before a major reorganization is undertaken.
IX: Closure of Drug Master File :
A holder who want to close the DMF should submit a request to the Drug Master File Staff stating the reason for the closure.
The request should include a statement that the holder’s obligations as detailed in Section VII have been fulfilled.
