Regulatory Focus™ > News Articles > New Draft Guidance Aims to Ease Process of Referencing Drug Master Files

New Draft Guidance Aims to Ease Process of Referencing Drug Master Files

Posted 01 October 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) has released new draft guidance on how it assesses the completeness of drug master files submitted to it under generic drug applications, aiming to streamline the process for all parties involved.

Drug Master Files (DMFs) are submitted to FDA, and contain confidential information regarding a specific company's processes, establishments or manufacturing capabilities. They are an optional submission, and may be used by FDA to more fully understand how a company operates.

Just before a drug loses patent protection, or sometimes just after, a company may choose to selectively allow access to its intellectual property in return for payments or other incentives. Though companies can show that a drug is identical to one manufactured by the innovative company, having identical manufacturing processes may allow a company to receive approval for its generic product more quickly.

Five types of DMFs exist, ranging from manufacturing, and drug substance production to packaging, finishing and reference information.

Type II active pharmaceutical ingredient (API) DMFs are used to support abbreviated new drug applications (ANDAs), which are used to obtain approval for generic drugs.

Under the terms of the Generic Drug User Fee Amendments (GDUFA), part of a sprawling FDA overhaul known as the FDA Safety and Innovation Act (FDASIA), holders of Type II DMFs are required to pay FDA a one-time fee when their file is referenced in a generic drug application or prior approval supplement (PAS) to an application.

As of 1 October 2012, if a DMF holder authorizes a third party to reference its DMF, known as a letter of authorization (LOA), the sponsor will need to pay a fee.

The guidance lays out which information should be included in the DMF in order for FDA to make a completeness assessment (CA), which includes a rundown of whether the DMF is active, whether its fee has been paid, if the DMF has been reviewed by FDA staff, which drug substances the DMF pertains to, if it contains administrative information, if the DMF contains enough information for a scientific review and if the DMF is written in English.

If DMFs are determined to be complete, they will be posted on FDA's website, "To indicate that the DMF is available for reference by generic drug applicants."

Comments on the draft guidance are due by 1 December 2012.

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