IPEC e-newsletter - Excipients Insight June/July 2017 - 10-07-17


Inside this issue


Less than a year to go before FDA's eDMF rules come in

From May 5, 2018, new drug master files have to be submitted using the current electronic Common Technical Document (eCTD) standard – and all submissions must be filed electronically even if the remainder of the master file is on paper.

In April, the FDA agreed to extend the deadline for eDMFs by 12 months by a year in response to industry comments and an internal review. At the time, it said: "Among other factors, FDA recognizes that there have been challenges with submission of master files in eCTD format, and eCTD uptake data for master files in particular indicated that adhering to the May 5, 2017 date 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."

Other documents, such as new drug applications (NDAs), abbreviated new drug applications (ANDAs) and biologics license applications (BLAs) were still held to the 2017 deadline.

According to the FDA, implementing electronic DMFs will improve the efficiency of the DMF review process, and will make it easier for the agency to review applications supported by DMFs.

The regulator says the first step to submitting DMFs electronically through FDA Electronic Submissions Gateway (ESG) is to request an ESG test account.




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