The FDA Move from Paper to Electronic DMF’s

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 US FDA no longer accepts paper formatted DMF’s.  The FDA move from paper to electronic reporting took longer than expected and included a year-long delay from 2018 to 2019.

You should not that 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.

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) 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.

The FDA has created a guidance document for the industry on the topic.  You can read it by clicking here.

What Can You Do?

We can help you if you have not had the capacity or the time to transfer your paper-based dossiers to an electronic format.   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.

Further Reading

eCTD & Publishing Services

Many companies choose to outsource all of their eCTD & Electronic Publishing needs to our team, while others seek our assistance on a project by project basis.  Our expert team, headed by Eileen Ryan, has extensive experience of working on behalf of clients and managing their submissions to authorities around the world.  The publishing sector is experiencing significant change at present with, among other issues, the change to mandatory eCTD.  Our team can assist you in every aspect of your publishing needs.  Read more about our services here.

Outsourced eCTD Publishing Services: An Overview

More countries are implementing eCTD.  As a result, more companies are being forced to make decisions regarding how they manage their electronic submission and eCTD publishing services.

We typically encounter three scenarios:

  1. Companies that maintain control of electronic publishing at the corporate and head office level
  2. Others that have retained the day-to-day eCTD maintenance and lifecycle at a local level
  3. Companies that have outsourced eCTD entirely

Read more here.