Master regulatory files

Master regulatory files are a set of documents the manufacturer of a drug or medical device has to furnish to the FDA. A Drug Master File (DMF) is a prime example of a kind of master regulatory files. Master regulatory files are provided to the regulatory authority to provide confidential information about the product, such as its design, the process, and the sample of the clinical trials and so on.

A firewall

Master regulatory files are what may be termed the blueprint for the product, because they contain all the vital information about the product. Information contained in master regulatory files is critical and acts as a ready reference for the regulatory authority. It protects the manufacturer from the risk of manipulation from other players in the field should such a situation arise. Master regulatory files may not have the same power or effect of copyrights or patents, but they contain important information about the product, nevertheless. They insulate the manufacturer from duplication and replication from competitors who may access the information about the drug or medical device.

Important points to remember about master regulatory files

Given the importance of master regulatory files; it is necessary to understand what is needed for its upkeep:

  • Documentation is at the heart of master regulatory files. Every step, small or big, has to be documented
  • Informed consent from the subjects who underwent the clinical trial
  • Record or copy of the approval obtained from the Institutional Review Board (IRB), which is the green signal for commissioning the clinical trial
  • Details of adverse events before, during and after the clinical trial
  • Details of storage of data
  • Clear instruction on whom in the organization maintains and updates master regulatory files and organizing them properly


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