Author

Marco Theobold

Director of Medical Device and Drug Services

Submitting Your Drug Master File to US FDA

Oct 17, 2023

A Master File is a voluntary submission that may be used to provide confidential detailed information to an agency such as the Food and Drug Administration (FDA). Master Files can include information about the facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more regulated products such as human drugs.  

Master Files allow parties to reference information without disclosing anything proprietary to other parties. Only FDA can review the information in the Master File when referenced in an application, such as a new drug application. Unlike other international agencies such as the European Medicines Agency (EMA), FDA treats the entire contents of the Master File as confidential. 

Master Files also cannot be either approved or disapproved. Instead, FDA reviews the technical contents of MFs in connection with the review of applications that reference them. 

Master File Types and Categories 

The following are the different categories of Master Files that may be submitted to FDA depending on the applications that will reference them. These are divided by industry and include: 

  • Drug Master Files (DMFs) 
  • Biologics Master Files (BMF or BB-MF) 
  • Veterinary Master Files (VMF) 
  • Medical Device Master Files (MAF) 
  • Tobacco Product Master Files (TPMF) 

Master Files are also organized into type based on the scope of confidential product, facility, or process information they will cover. The five types of Master Files are: 

  • Type I: Manufacturing site, facilities, personnel, and operating procedures (No longer accepted or maintained) 
  • Type II: Drug substance, intermediate and material used in preparation of drug or drug product 
  • Type III: Packaging material  
  • Type IV: Excipient, colorant, flavor, essence, or material used in their preparation 
  • Type V: Manufacturing and control facilities information; references concerning drug products and other material 

FDA Requirements for Master Files 

Most Drug and Biologics MFs must be submitted in electronic Common Document Format (eCTD), while Veterinary and Tobacco Master Files are required to be in eSubmitter format. MAFs, on the other hand, should be submitted using eCopy format. Most master file submissions may be submitted to FDA using the Electronic Submissions Gateway (ESG). 

It is important for companies to be aware of any additional requirements that may incur from submitting a particular type or category of Master File. For example, those submitting Type II Active Pharmaceutical Ingredient Master Files may incur a one-time Generic Drug User Fee Amendments (GDUFA) fee if their DMF is referenced in a generic drug application. 

Submitting a Master File successfully to FDA is a time-consuming, complicated process, but working with Master File Specialists can make all the difference. At Registrar Corp, we’re committed to helping our clients properly file their Master Files for all FDA-regulated industries.  while also protecting your confidential intellectual property.  

Learn more about how we can assist your Master Files submissions to FDA today. 

Author


Marco Theobold

Director of Medical Device and Drug Services

A highly regarded expert in medical device and drug regulations by the U.S. Food & Drug Administration (FDA), Marco brings a unique perspective for medical device and drug companies seeking to distribute products in the United States. He proudly provides guidance on FDA regulations for pharmaceutical, medical device, and radiation emitting device (RED) companies.

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