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 submissions 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.