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FDA Extends Deadline for eCTD Submissions of Type III DMFs to May 2020

February 6, 2019

The U.S. Food and Drug Administration (FDA) has extended the requirement to submit all new Type III Drug Master Files (DMF) applications, as well as all documents submitted to existing DMFs, in Electronic Common Technical Document (eCTD) format, to May 5, 2020. Type III DMFs are for packaging materials.

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, which was published on January 31, 2019.

By way of background, FDA first issued the guidance document mentioned above on May 5, 2015. The original guidance document specified that sponsors and applications were required to submit investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs) in electronic format by certain dates, ranging from May 2017 through May 2018. FDA further stated that it considers DMFs to be submissions to an NDA, ANDA, BLA, or IND, and, therefore, subject to the deadlines. The original deadline for submitting Type III DMFs in eCTD format was May 5, 2017.

This is the third time FDA has extended this deadline. When FDA announced in April 2018 the second extension to May 5, 2019, it explained that the deadline was being extended due to the possibility of a high rejection rate of DMF submissions in eCTD without the extension. The Agency further explained that “because Type III DMFs typically provide information regarding packaging or packaging materials in support of NDAs, ANDAs, or BLAs should submitters choose not to submit or to no longer support existing Type III DMFs, this could lead to drug supply interruptions.” Concerning the most recent deadline extension to May 2020, FDA stated that many of these concerns remain.

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