Drug Master File—Electronic Submission through eCTD: An Overview

Abstract

A Drug Master File (DMF) is a supporting document for various applications such as Investigational New Drug Application (IND), New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Biologic License Application (BLA), etc. Mainly product’s chemistry, manufacturing, and control (CMC) part is covered in the DMF. As per the current guidelines of US Food & Drug Administration (USFDA), all types of DMFs are mandatory to be submitted through Electronic Common Technical Document (eCTD) only, except for Type III DMFs for which date is extended to May 5, 2020. For the electronic submission of DMFs, there are few steps needed to be completed such as obtaining the pre-assigned application number, converting DMF to eCTD format, setting up an Electronic Submission Gateway (ESG) account, and submission through ESG to the FDA. Electronic submission using eCTD makes submission and review by the FDA both easy, though there are many mistakes done by the submitter which leads to rejection of the electronic submission. The FDA has made available all the required guidance documents for setting up an ESG account and submission through eCTD so that the number of rejections of submission can be reduced.

Keywords: drug master file (DMF), electronic submission, eCTD, master file

Cite this Article

Y.Patel, A.Pathan. Drug Master File—Electronic Submission through eCTD: An Overview. Trends in Drug Delivery. 2019; 6(1): 8–13p.