FDA’s API DMF Assessment Timelines Improve as eCTD Use Increases and OPQ’s New API Review Structure Takes Hold

The increasing use of the electronic common technical document (eCTD) for submitting Type II Drug Master Files (DMFs) has contributed to a significant reduction in the amount of time it is taking FDA to do DMF completeness assessments (CA), and a significantly higher percentage of the electronic filings are clearing the CA review on the first cycle compared to the paper versions.

During the first six months of the Generic Drug User Fee Act (GDUFA) – October through April 2013 – about 20% of Type II DMFs were submitted in electronic format, compared to 50% by the end of Year 3 (FY 2015). 

Meanwhile, the average number of days it took the agency to finish a full completeness assessment once the filing fee is paid dropped from 108 to 73 – well on the way to the agency’s goal of 45 days.

The time to do an “administrative” CA on a DMF for which a full scientific review has already been conducted has shrunk during the three years from an average of 20 to 9 days – seen by OPQ as about the efficiency limit. A completeness assessment either results in the DMF receiving a “complete” designation or the issuing of an incomplete letter to the filer.   

In turn, the data from the FDA’s Office of Pharmaceutical Quality (OPQ) is showing that about half of the CAs are being completed for electronic DMFs on the first cycle, versus only about 20% for the paper filings.

The more efficient DMF review process flowing from eCTD use was highlighted by OPQ Office of New Drug Products (ONDP) Chemist Jayani Perera during her update on the DMF assessment process and results presented at a track on active pharmaceutical ingredient (API) reviews on the third day of the GPhA/FDA Fall Technical Conference in November.

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