eCTD Mandate at FDA
So what do you need to know for the upcoming mandate from the FDA to switch submissions to electronic? How long do you have to make the switch? When should you begin making the switch?
All of these questions are ones which are important not only for understanding, but also for long term planning. And here's the most important part. It covers every aspect of your company, not just Regulatory. Yes, it is a filing, so you would think that it is just a Regulatory issue, but it covers IND, NDA, ANDA, BLA and Master Files, all which draw upon other departments. This new mandate takes effect on 05 May 2017 for NDA, ANDA, BLA, and Master File submissions. Commercial INDs get added to the mandate one year later. Converting any of these files to electronic is not a simple task, and it is one that will require some work on the part of your Regulatory Operations internal team or external contractors, depending on how you are set up.
The 05 May 2017 date is a deadline, and not the start of the process. That is the day by which you have to be finished. As we are approaching the end of the year, and the FDA goes into a lower operating Tempo between Christmas and New Year, I would recommend beginning the switch over shortly after the New Year. That gives you five months to be able to not only make the switch, but also ensure that you have properly QCed your documents, and checked that all the linking works.
This is not something you should wait until the last minute to do. I would also recommend going forward that every submission you do from this point on is electronic in nature. If you have not invested in a Regulatory Operations Team, this may be the time to start considering a good one. A good Regulatory COnsultant can also walk you through what the requirements are, and how they apply to your existing submissions.
The important thing to remember is that you have six months to get this done, so the clock is ticking.
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