DMF stands for Drug Master File which contains confidential information related to the manufacturing, control or chemistry of the product. A US DMF filing is the provision made by the US FDA to maintain the confidentiality of the information in the DMF Filing. The Manufacturer of the Drug, excipient, or packaging material can directly submit the product related confidential information to the FDA without disclosing the information to their customer. However, the manufacturer may have to disclose parts of the DMF such as product specifications and general information to their customer, since such information is mandatory for product development and quality control related activities.
The Manufacturer of the DMF submits the DMF to the FDA and provides a letter of authorization in the name of their customer. The FDA reviews the DMF in connection with a drug application such as ANDA/NDA/ANADA. In other words, the FDA does not review the DMF as stand-alone, since during the DMF review, the FDA considers factors such product strength, nature of the product, and maximum daily dosage. Therefore, DMFs are neither approved or disapproved.
The FDA performs an initial assessment of a Type II drug master file as per the completeness assessment checklist published by the FDA to verify the presence of mandatory required information in the Type II DMFs. After successful outcome of the completeness assessment the FDA publishes such DMFs in the Available for Reference List which provides assurance to the generic drug applicant about the DMF submitted by their supplier.
In order to pass FDA completeness assessment, DMF must be prepared according to FDA DMF guidelines and must include all the mandatory information.
It is a mandatory requirement to submit the DMF in the eCTD format. eCTD is an electronic common technical document which contains xml backbones with meta data and eCTD documents organized as per the ICH eCTD specification.
The FDA maintains the list of DMFs, name and DMF number for all the products which have completed administrative review can be found in the FDA DMF database. The FDA DMF list is updated quarterly, with newly submitted DMFs.
Drug Master File holders must submit an amendment if there are any changes in the DMF and submit a report annually.
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