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FDA Extends Deadline Requiring Drug Master Files in Electronic Format

The U.S. Food Drug and Administration (FDA) announced on April 7, 2017, that the requirement to submit all new Drug Master File (DMF) applications, as well as all documents submitted to existing DMFs, in Electronic Common Technical Document (eCTD) format will be extended by one year, from May 5, 2017 to May 5, 2018. The new deadline was included in an update to the guidance, Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.

In the updated guidance, FDA states that the deadline extension is in response to industry comments and internal review. Explaining, the Agency wrote, “Among other factors, FDA recognizes that there have been challenges with submission of master files in eCTD format, and eCTD uptake data for master files in particular indicated that adhering to the May 5, 2017 date could have led to high rejection rates of master files and thus slower FDA review processes, and, therefore, potential unnecessary delay in the review of some drug applications.”

For an overview of FDA’s drug packaging regulations and background information on the requirement to transition DMFs to an eCTD format, see the article, The Latest on Drug Master Files for Packaging Materials in the United States—and a Little History.