eCTD submission

FDA Delays eCTD Requirements for Master Files

As per guideline released on friday, FDA announces delay in submission of DMF in eCTD format until 5th may 2018

Final Guideline is available here : FDA Delays eCTD Requirements for Master Files

Beginning on May 5, 2018, new DMFs, as well as all documents submitted to existing DMFs, must be submitted using the Electronic Common Technical Document (eCTD). DMF submissions that are not submitted in eCTD format after this date will be rejected.

Information for current DMF holders

If a DMF is in paper format with FDA, the same submission does not need to be resubmitted in eCTD format. However, starting May 5, 2018, any new submissions to the existing DMF must be done in eCTD format. The DMF holder may continue to use the same DMF number. If the existing number is four-digits, e.g., 1234, the DMF holder will need to pad left with zeroes to convert the DMF number to a g-digit format, e.g., 001234 when the DMF is converted to eCTD format. In addition, if the DMF holder chooses to resubmit all of an existing paper DMF in eCTD format, and there are any changes in the content of the DMF as a result of the reformatting (e.g., addition of new or updated information), the Cover Letter for the submission should specify what areas of information have been updated.

Other documents, such as new drug applications (NDAs), abbreviated new drug applications (ANDAs) and biologics license applications (BLAs) must still meet the 5th May 2017 deadline.

As per the guideline FDA mentions why dealine has been extented. FDA joted down by the comments received from the industry and internal review 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 5th May 2017 date could have led to high rejection rates of master files and thus slower FDA review processes

Our team can assist you to fulfill the US FDA DMF requirements, our service includes:

  • Module 1 document mapping and granularity management
  • DMF life cycle management including the amendments and annual report
  • DMFs that cover multiple items, e.g., container closure systems (Type III) or Flavors (Type IV) in eCTD
  • Electronic Signatures in DMFs
  • US FDA specific Document formatting and publishing
  • Navigation Aid Management including the table of contents and hyperlinks
  • Dossier assembly and compilation in eCTD format
  • Paper to Electronic document conversion to provided searchable text based documents as required by US FDA
  • For small sized API companies, we provide Pay per Dossier conversion to create eCTD based DMF submissions

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