The US FDA DMF Deadline: 5 Things You Need To Know

The transition from paper based submissions to electronic Common Technical Document (eCTD) has continued in recent years.  This is something that we have covered on this website on a number of occasions.  The next deadline of note is that of the US Food & Drug Administration (FDA) Type III Drug Master File or DMF deadline.  That deadline is May 5th 2019 and right now we are assisting many companies in converting their paper based DMF’s in to the eCTD format.  The FDA decided in April 2018 to extend the deadline by one year.  Type II, type IV, and type V DMF submissions to FDA have only been accepted in eCTD format since May 5, 2018

Here are 5 things that you need to know about the FDA’s transition from paper based DMF’s to eCTD submissions:

1) All master files and documents submitted to existing master files must be submitted in eCTD from May 5th 2018.

2) What is a master file?  The FDA considers a master file to be any of the following:

 NDA New Drug Application
 ANDA Abbreviated New Drug Application
 BLABiologics Licence Application
 INDInvestigation New Drug Application
 DMFDrug Master File
 BPFNew Biological Product Files

and any amendments to/or annual reports on previously submitted DMF’s and BPF’s.

3) After May 5th 2019 the FDA states that there will be NO waivers or exemptions for Drug Master Files that are not in the eCTD format.

4) Companies submitting just part of a DMF need only provide the new information in the eCTD format.  Subsequent submissions must be made electronically.

5) You must submit electronic submissions using the Data Standards Catalog which is the FDA supported version of eCTD.

Typically DMF’s do not require specific forms, however, the exception to this is the Generic Drug User Fee Cover Sheet (otherwise known as form 3794) that applies to Type II API DMF’s that support ANDA’s under the Generic Drug User Fee Act (GDUFA).  The FDA will not accept scanned images. of FDA documents.

What Can You Do?

Time is ticking as the DMF deadline approaches.  We are happy to help with an eCTD or DMF related query that you might have.  Our publishing team is currently assisting a number of companies on FDA DMF related issues.  Contact us on 00353 52 61 76706, email us:  info@acornregulatory.com or simply fill in your details below and we will get back to you.

You can read more about eCTD on the Acorn Regulatory website here.