IPEC-Americas Publishes Position Paper on Utility of US DMFs for Excipients

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IPEC-Americas published a position paper in response to misconceptions regarding DMFs.

IPEC-Americas published a position paper on Jan. 4, 2017 on the utility of drug master files (DMFs), the organization said in a press release. The purpose of the paper is to “help industry review and reflect on the real purpose and/or utility of excipient DMFs,” IPEC said in the paper. This is in part because “although the FDA has stated that there is no requirement to convert information contained in existing paper DMFs into electronic CTD [common technical document] format, it will be realistically impossible long-term for excipient suppliers to maintain paper DMFs since all future updates, amendments, annual reports and Letters of Authorization (LOAs) will be required to comply with eCTD format and electronic submission specifications.”

The IPEC-Americas position paper was developed in response to misconceptions regarding excipient DMFs and the many changes occurring in DMFs, including the conversion by FDA to eCTD format for future modifications, additions, and submissions. The position paper lists recommendations for the submission and maintenance of DMFs, thoughts regarding justification of the costs of DMFs versus providing confidential information directly to customers for submission in the customers’ regulatory filings, considerations for inactivating compendial excipient DMFs, thoughts regarding the sharing of excipient information for drug application support by excipient suppliers to their customers, and alternative sources for the information commonly found in some excipient DMFs. The position paper also seeks to clear up some of the most common misconceptions regarding excipient (Type IV and V) DMFs and to provide some situations where establishment of a new excipient DMF may be advantageous.


Source: IPEC-Americas