Focus on DMF, eCTD & Electronic Publishing

The decision by the US Food & Drug Administration (FDA) to delay the requirement for companies to submit all new Type III Drug Master Files (DMF’s) in eCTD has been delayed until May 5th 2019. 

The requirement, initially scheduled for May 5th 2018, has been welcomed by many in the pharmaceutical sector.  The FDA has explained the delay in introducing the requirement on the possibility that a higher than usual number of DMF’s might have been rejected had the extension not been granted.  In a statement about the extension of the deadline, the FDA said “because Type III DMF’s typically provide information regarding packaging or packaging materials in support of NDA’s 9new drug applications), ANDA’s (abbreviated new drug applications), or BLA;s (biologics licence applications), should submitters choose not to submit or to no longer support existing Type III DMF’s, this could lead to drug supply interruptions”.  It should be noted that the extension only applies to Type III DMF’s.

The DMF issue is one that we have been assisting many companies with in recent times.  We have written extensively on eCTD and electronic publishing issues. Below, we have highlighted a number of relevant articles written by our expert staff.

Baseline Submissions & The January 1st NeeS Deadline

We have written extensively on issues relating to electronic publishing of submissions.  In fact, Acorn Regulatory was one of the very first companies to embark on electronic publishing on behalf of client companies many years ago.  As the eSubmission Roadmap continues apace we are now looking to the next deadline of January 1st 2019 when all regulatory activities in National Procedures (NP) will need to be completed in eCTD.  Read more here.

Mandatory eCTD: What You Need To Do

Now that eCTD is mandatory, you need to ensure that your dossiers are in the eCTD format.  In this article we look at mandatory eCTD and what you need to do.

The eCTD format is required for all new MAAs submitted under National Procedures by 1 July 2018 and for all regulatory activities affecting National Procedures from 1 January 2019. According to the annex   “regarding the eSubmission Roadmap, on an average, approximately half of all National Procedures were submitted in eCTD format in EU, in some NCAs even 100%. Some NCAs have already announced their intentions to require eCTD format submissions for purely Nationally Authorised Products (NAPs) to achieve simplifications of processing and working with dossiers regardless of the procedure type and regulatory activity at any level. Read more here.

Outsourcing eCTD – Is This The Right Time?

We have referenced it before on our blog: the life sciences sector can learn a lot about outsourcing from the airline industry. In particular, companies should consider outsourcing eCTD projects. Read more here.

If you would like to discuss DMF or eCTD issues with us, then please get in touch.  You can call us on 00353 52 61 76 706 or complete your details below: