FDA Deadline Extension for DMF Submission in eCTD Format

As said and done for many times till now, the United Sates Food and Drug Administration (USFDA) has set a compliance deadline for eCTD (electronic common technical document) submissions. The deadline for the first phase is on 5th May 2017 and for the second phase, it is on 5th May 2018. What’s there to reconsider now? The US health authority has extended the date of compliance for drug master files (DMFs) and Biological Product Files (BPFs) till 5th May 2018, i.e. aligning it with that of Commercial INDs deadline. However, all the NDAs, ANDAs and BLAs must be submitted in the eCTD format meeting the first phase deadline.

With the announcements, have taken place since a year on DMF eCTD 2017 deadline, why a sudden change/push at the brink?

FDA quotes the move as a response to concerns that some companies might not keep up with rapidly approaching deadline. It is learned through industry comments and internal reviews that there have been some challenges for companies to get prepared for the eCTD format and master file data uptake within the timeframe. Submitting the incomplete version could lead to higher rejection rates affecting both the FDA’s time for multiple reviews and DMF holders’ costs. Hence the motto behind the deadline extension was to ease the challenges enroute compliance.

Now it is clear that excluding DMFs, the May 5th 2017 deadline for NDA, ANDA and BLA electronic submissions is active. With that reiterated, all the DMF holders can bask in the glory of deadline extension for end-to-end preparedness. But the complexities surrounding the data collation and formatting it for eCTD ‘18 submissions remains as is. The same deadline worries might challenge you for preparations. Paper to eCTD conversion could be anything but a cake walk. With the commercial IND eCTD submissions, also in pipeline for 2018, how could you shift in-between? Run ahead of the time to be audit-ready. Chose an expert publishing and submission partner.