Any step you make to transition to the electronic file format is desirable as it aids the reviewer. That being said, I highly suggest (if you don't already know it), find out the name of your reviewer and ask them directly. You might find that they would like to actually get a copy of the Annual Report via email (or say no altogether). You might open up the door in regards to digital certificates and encryption - but since it is only 1 submission a year and a very specific type you will find a range of answers depending on the FDA contact to which you are involved. Your company may have special needs/rules in regards to data transmission by email (at least one of the customers I serve has moved to file sharing to transmit information for Annual Reports).
You also need to consider 21 CFR Part 11 if the only copy you will retain will be a CD and or other electronic media format (What is your planned file copy?). You'll have to ensure longevity of your copy regardless of its' format. If you are already working inside an electronic file management system, another suggestion is to transition to what I like to call smart PDFs. Create them like they are eCTD but in IND format. This will help you/your publishing group get used to some typical regulatory operations functions and you might even run into some additional software needs once you start trying the format. Baby steps and small costs to fix if you're company is not quite yet ready to move.
Hope that helps!
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Tracy Ulderich, MS RAC
Regulatory Affairs Scientist
SAIC
Frederick MD
United States
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Original Message:
Sent: 03-15-2012 16:04
From: Alison Trado
Subject: Annual Report PDF File Format
Hello all,
I work for a small pharma company that still submits to FDA in hard copy format and we are not even close to moving into eCTD format. So, I would like to start transitioning the company into an electronic format starting with the annual report. My first step is to submit the AR in pdf file format. My experience from my previous job was that FDA asked us to submit in pdf file format with the cover and 2252 in hard copy. However, we have not been asked by FDA to submit in pdf file format so I am asking you if I need to get approval from FDA to submit in this format before sending? Your help on this transition is appreciated.
Thank you.
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Alison Trado
Regulatory Affairs Manager
Hill Dermaceuticals, Inc.
Sanford FL
United States
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