FDA Adds Submission Type to Delayed eCTD Implementation Requirements

Regulatory NewsRegulatory News | 25 April 2018 |  By 

In the fifth version of US Food and Drug Administration (FDA) final guidance released Wednesday, the agency added a deadline for Type III drug master file (DMF) submissions in electronic common technical document (eCTD) format.

The updated guidance—which implements the requirements, under the FD&C Act, for eCTD submissions to FDA—delays the deadline for Type III DMFs for an additional year, compared to the upcoming 5 May 2018 deadline for commercial investigational new drug (IND) applications master files other than Type III. It also provides a rationale for extending the Type III DMFs implementation date to 5 May 2019.

“FDA has determined that application of the electronic submission requirement to Type III drug master files (DMFs) on May 5, 2018 could lead to high rejection rates of these submissions,” FDA said.

Since 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 agency added. “Given this, the burden on the agency of allowing non-eCTD submissions for Type III DMFs during this interim period is expected to be low."

In the fourth revision of the guidance from April 2017, the agency also delayed eCTD requirements for commercial INDs by one year.

FDA’s decision was made in response to industry comments raising concerns about “challenges with submission of master files in eCTD format, and eCTD uptake data for master files” that “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” with adherence to the previous date.

The implementation for new drug applications (NDAs), abbreviated new drug applications (ANDAs), certain biologics license applications (BLAs) was 5 May 2017.

Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications: Guidance for Industry


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