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|
|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) 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: firstname.lastname@example.org or simply fill in your details below and we will get back to you.
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.
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:
- Companies that maintain control of electronic publishing at the corporate and head office level
- Others that have retained the day-to-day eCTD maintenance and lifecycle at a local level
- Companies that have outsourced eCTD entirely