FDA Pushes Back eCTD Deadline for Type III DMFs Again

Regulatory NewsRegulatory News | 29 January 2019 |  By 

Ahead of the 5 May 2019 deadline set last April, as the required date for Type III drug master file (DMF) submissions in electronic common technical document (eCTD) format, the US Food and Drug Administration revised final guidance to reflect a new one-year delay on the implementation date.

The sixth version of the final guidance for compliance with eCTD requirements was posted Tuesday to push the date back again after version 5 provided an extension from the previous 5 May 2018 date. FDA cited ongoing concerns over issues submitting master files in eCTD format and risk of slower reviews.

“FDA determined that many of the concerns outlined” in the final guidance still remain since the April 2018 publication of version 5, the agency said. “Therefore, the agency is issuing a revision to this guidance to further extend the implementation date for Type III DMFs until 5 May 2020.”

The revised guidance further clarified that the effective date for Type III DMFs in eCTD format is now 60 months after the 5 May 2015 date of its original finalization. It was first finalized under version 3.

Meanwhile, FDA has been internally working on the development of a system dubbed the Knowledge-aided Assessment & Structured Application (KASA) over the potential advantages that the new platform is believed to have over the eCTD system. Last September, FDA chemical engineer Larisa Wu pointed to how the eCTD system does “not follow the development flow of the drug product” and “contains unstructured data in text-based PDF files” that can lead to “redundancy and lengthy assessments.”



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