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 DMFs. The FDA move from paper to electronic reporting took longer than expected and included a year-long delay from 2018 to 2019.
You should note 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 |
| BLA | Biologics Licence Application |
| IND | Investigation New Drug Application |
| DMF | Drug Master File |
| BPF | New 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 DMFs that support ANDAs 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 at 00353 52 61 76706, email us: at info@acornregulatory.com or simply fill out the form on our Contact Us page and we will get back to you.
