DMF – DRUG MASTER FILES

A Drug Master File (DMF) is a document submitted by a drug manufacturer to US FDA which is used to provide confidential detailed information about facilities, procedures, or things used in the manufacturing, processing, packaging, and storing of one or more human drugs. A DMF is submitted when more companies work in partnership to manufacture a drug product, which allows the company to protect is its intellectual property rights from its partner while complying with regulatory constraints as well for disclosing of processing procedures.

DMF’s are submitted to support regulatory regulations and prove the quality, safety and effectiveness of a product for getting Investigational New Drug Application (IND), New Drug Application (NDA), Abbreviated New Drug Application(ANDA), another DMF and Export Application. However, DMF submission is NOT a substitute for an IND, NDA, ANDA or Export Application. As per FDA regulation, DMF submission is not required by law, it is solely depends to submitters discretion.

As per FDA, there are five types of DMF’s

• Type I  : Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)
• Type II  : 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

All DMF submissions must be in the English language which should contain transmittal letter, administrative information about the submission and must include specific information about the DMF type.

All foreign DMF holders are required to appoint an U.S agent, however domestic DMF holders do not need a representative to submit it.

DMF holders should submit an annual report on the same date of their original submission.  Annual report should contain all the information including name and address of DMF holder, corporate headquarters, Manufacturing/ processing facility, contact for FDA communication, agents (if any),statement of commitment and signed statement by the DMF holder assuring that the DMF is current.

Starting from May 5, 2018 onwards, new DMFs other that Type III, as well as all documents submitted to existing DMFs excluding Type III are required to submit DMF using Electronic Common Technical Document (eCTD).  DMFs that are not submitted through eCTD after May 5, 2018 will be rejected, however for Type III DMFs the requirement will be effective from May 5, 2020 onwards.

Liberty Management Group Ltd, a leading FDA consulting group in the United States, provides assistance DMF eCTD submissions, US agent service, DMF closure and reactivation request submission to FDA.

Sudha S

Regulatory Consultant

Mail: office@libertymanagement.us

http://www.fdahelp.us