FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Extends Type III Drug Master File E-Submission Compliance Date

Feb. 5, 2019
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The FDA issued revised guidance on electronic submissions of drug master files, extending the timetable for Type III submissions by another year to May 5, 2020.

In an April 2018 revision, the agency had previously provided a one year extension through May 2019, noting that keeping the original date could lead to high rejection rates and drug supply interruptions.

The guidance also outlines types of submissions that must comply with the electric submission requirement. They include NDAs, certain INDs, ANDAs and certain BLAs. The requirement to electronically submit ANDAs, BLAs and NDAs became effective 24 months after the guidance’s original finalization date, May 5, 2015. For INDs and master files other than Type III DMFs, the requirement kicked in 36 months after May 5, 2015, or May 5, 2018.

Any amendments must be submitted electronically even if the original submission was submitted prior to implementation of the electronic submission requirements, the agency said.

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