FDA Extends Deadline for Type III DMF Submissions in eCTD to May 5, 2019
The U.S. Food and Drug Administration (FDA) announced on April 24, 2018, that the requirement to submit all new Type III 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, 2018 to May 5, 2019. This is the second time FDA has extended this deadline; last year, the Agency similarly announced a one-year extension just a few weeks prior to the original May 5, 2017 deadline.
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.
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 considered 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.
As mentioned above, this is the second time FDA has extended the deadline. This time, FDA stated 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.” The extension only applies to Type III DMFs.
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.