DMF Full Form, Definition, Objectives, Types, Requirements

DMF stands for Drug Master Files.

What is DMF?

A Drug Master File or DMF is a document prepared by a drug manufacturer and submitted to the appropriate regulatory authority for the target drug market at its sole discretion. There are no regulatory requirements for submitting a DMF. However, this document provides regulatory authorities with confidential details regarding facilities, processes, or items use to manufacture, process, pack, and hold one or more human medicinal products.

A Drug Master File (DMF) is a submission to the FDA to provide confidential details about facilities, processes, or items use to manufacture, process, pack, and store human pharmaceuticals.

Allows interested parties to view the materials without disclosing the DMF content. They are not required by law or regulation.

It is neither approve nor rejected. Instead, FDA reviews the technical content of DMFs in the context of reviewing submissions (NDAs, ANDAs, INDs, BLAs, etc.) that reference DMFs.

Objectives of DMFs

The primary purpose of DMF is to support regulatory requirements for pharmaceutical products to demonstrate their quality, safety and efficacy. Moreover, this helps you gain market approval as it speeds up the whole process. However, the implementation of the eCTD format in May 2018 made the DMF submission process simple and easy. API or DP manufacturers worldwide can submit DMFs to the FDA through the FDA's online platform.

Types of DMFs

However, there are four types of master files:

Type II: APIs, pharmaceutical intermediates, and materials or pharmaceuticals use in their manufacture

Type III: packaging material

Type IV: Auxiliaries, dyes, fragrances, essences or materials used in manufacturing

Type V: FDA-approve reference information

Moreover, in 2000, Type I Master Files were discontinue, but the numbering of other types of Master Files remaine the same.

FDA Processing and Reviewing

1. Administrative Review

Once the FDA has reviewe and accept the control information, a confirmation letter will be sent to the DMF holder. However, this letter contains the DMF number, subject (title), owner type and name. If any information is missing, FDA will notify the DMF holder. Moreover FDA will only initiate a technical review once administrative issues are resolved and the DMF is reference in the applicant's or sponsor's application or other DMF.

2. Technical Review

FDA does not review or approve DMFs on its own; it reviews DMFs only as part of an applicant's or sponsor's application. Therefore, DMF technical information will be review by FDA once an approve party submits a copy of the DMF owner's LOA in the relevant application or another DMF. However, FDA will notify DMF holders if additional information is necessary to support approval of the application. Moreover, if the FDA recommends that additional information be include in DMF, the DMF holder can be sent a recommendation/request for information form.

DMF Closure

If the DMF is not guarantee to be current and the DMF owner does not submit timely annual reports, the FDA may close the DMF. FDA may also close DMF following a request for closure by a DMF holder. However, a DMF holder must submit an administrative change for closure and notify all eligible parties. If a DMF holder wishes to have DMF restored, she must provide a new DMF. Moreover, it can be submitted to the FDA to replace the close DMF.

Requirements for DMF Submission 

Each DMF transmission has specific requirements:

• Transmittal Submission – The original transmittal letter must be given and include the type of DMF and its subject.
• In-depth Administrative Information – Administrative information must include the DMF owner's name, headquarters, manufacturing facility, contact information, and representative information (if applicable).
• Information on the DMF must be in English – If the DMF is submitted in a language other than English, it must be accurately translate, and a certificate of translation must be attache to the DMF.
• All DMF modifications must be reporte as modifications, and owners must notify authorize parties of file modifications.

Significance of Holding a DMF

DMF helps to own companies reduce processing time for INDs, NDAs, ANDAs, or export applications by reducing the total number of verification cycles. Moreover and increase your chances of admission in the first cycle. Additionally, holders with a large number of DMFs are considered more trustworthy in terms of quality, regulatory concerns, and ability to meet current Good Manufacturing Practice (cGMP) requirements.

Moreover owning a DMF, therefore, strengthens an API maker's position against its competitors by building customer trust and thereby increasing its sales potential worldwide. However, it also helps in penetrating the high barriers to entry into the US market. However, possession of DMF for API or DP does not confirm that the company is authorize to manufacture or supply this product in the United States.

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