While the first year only saw three electronic submissions, CDER is now accepting over 8000 electronic documents per month. With a looming deadline of 2015 to achieve a 100% electronic submission goal – there is still quite a bit of work to do. To better quantify the transition progress, >80% of NDA submissions and >60% of IND submissions are currently electronic.
The desire from the FDA to make the transition is to reduce review time and accuracy when sifting through submissions that may be thousands, or tens of thousands, of pages long. The desire for submitters is not as clear cut. In general, big pharma companies with a depth of submissions and infrastructure to support the change have made the switch; small companies have not.
“It’s a huge undertaking, especially for smaller companies that may only have a handful of submissions annually, but it’s the future of the drug approval process” said Jeff Coderre, Ora’s Manager of Regulatory Writing. Having been involved in more than 30 FDA drug approvals over the years, the Ora regulatory team is well seasoned when it comes to the ins and outs of regulatory submissions. Writing protocols, clinical study reports, FDA correspondence, and FDA meeting briefing packages – it’s all part of the regular daily life for the regulatory writing team at Ora.
The structure and format of an electronic submission to the FDA is precisely defined. The FDA’s Electronic Submissions Gateway automatically checks submissions for errors, and if found, the submission may be rejected. All of the sections of these very large documents are organized along an “XML backbone” (XML is short for Extensible Markup Language) and in many ways is analogous to a web page where text and images are organized with HTML (Hypertext Markup Language). In fact, you can view an XML-based electronic submission with a conventional web browser. Specialized XML-reading software provides much more, allowing users to navigate throughout a large document with hyperlinks and to see the submission history (older sections that have been updated). Once all of the content has been electronically published, i.e., assembled along the XML backbone, it is ready to be electronically submitted to the FDA.
Coderre points out that with an anticipated mandatory electronic submission deadline of 2015, “it’s important to be ahead of the curve so there’s time to respond to unanticipated changes in the submission process”.