What Is Drug Master File (DMF) Submission?
Drug Master File (DMF) submission is a classified document that is submitted to the U.S. Food and Drug Administration (FDA) and entails detailed data regarding the manufacturing, processing, packaging or storage of the components employed in the pharmaceutical drug products. This filing assists the companies to provide the FDA with important information, but protect their proprietary information against applications by competitors as well as other third-party regulators.
What is the Purpose of DMF Submission?
Pharma firms may tend to outsource vital products which are active pharmaceutical ingredients (APIs), excipients or packaging materials. Rather than presenting their clients with the specifics of manufacturing processes, such suppliers forward a DMF to the FDA. This enables FDA to extensively review the data in the evaluation of the drugs application without leaking the trade secret of the supplier.
DMFs facilitate different drug usage applications and they include:- New drug applications (NDAs)
- Abbreviated new drug applications (ANDAs)
- Investigational New Drug Applications (IND’s)
- Biologics License Applications (BLA)
Pharmaceutical companies that include an indication of a DMF during their application of a drug can minimize their input and prevent the obsolete duplication of confidential information.
Types of Drug Master Files
Depending on their content and purpose the FDA classifies DMFs into the following types:- Type II: Pharmaceutical substances, drug-substance intermediaries and material used to manufacture them
- Type III: Drug products packaging materials
- Type IV: Essences, flavours, colorants and excipients
- Type V: FDA recognized or Miscellaneous reference information that does not fall into the other categories
What is Included in a DMF?
A typical comprehensive DMF will comprise of:- Descriptions of the manufacturing process in detail
- Quality control specifications and tests
- Shelf life data on demonstrating product stability
- CMP manufacturing sites and machines data
- Validation studies and control of environment measures
These are all in the format of a Common Technical Document (CTD) and are electronically submitted using the Electronic Common Technical Document (eCTD) system, which standardizes submission and makes it easier to assess by the FDA.
The Review and Submission Process
The DMF holder reports it to the FDA through direct file. The DMF holder provides such a DMF with a Letter of Authorization (LOA) when it is requested by a drug manufacturer that is seeking to include a DMF are within a drug application. This letter would allow FDA to inspect the confidential DMF content as a component in the application submitted by the applicant, but it would hide the information against the applicant.
It should be realized that DMFs are not considered by the FDA. Rather the FDA will review DMFs only as they are drawn upon in another regulatory application. Thus, the DMF holder has a responsibility to maintain an accurate, up-to-date DMF. They should also immediately reply to requests made by the FDA and modify them in case of change in details.
Benefits and Challenges of DMF Submission
The DMF submissions offer means of safeguarding sensitive manufacturing information that enhance cooperation between suppliers and drug manufacturers. Such secrecy provides international innovation and business security and regulatory compliance. Nevertheless, a DMF is easy to maintain. It should be regularly updated, frequently documented, and communicated with FDA and reference companies. Failure to fulfill these duties may result in lagging drug approvals and business relationships.
Drug Master File submissions are needed to achieve regulatory transparency and business confidentiality. They enable the FDA to obtain crucial manufacturing information required during the drug safety examination and safeguard proprietary data.
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