Are You Ready to Meet FDA’s Strict eCTD Requirements?

Jim Nichols

Jim Nichols, COO, Cunesoft

The U.S. Food and Drug Administration (FDA) has given industry nearly three years to get ready to handle submission of the electronic common technical document (eCTD), so don’t expect much sympathy from the agency today if you don’t comply, says Jim Nichols, COO at Cunesoft.

After a few delays, using an eCTD to file the various clinical trial–related key applications, amendments, supplements, and reports to FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) is now the law of the land. However, some sites, notably hospitals, have been struggling to meet FDA’s expectations.

“They’ve been submitting a couple of Microsoft Word documents and print them or e-mail them to the reviewer,” Nichols says, but adds that meeting compliance standards requires, among other things, very specific software. “It isn’t something that you can just figure out how to write yourself on Notepad or something.”

FDA defines eCTD as an interface for industry-to-agency transfer of regulatory information while at the same time taking into consideration the facilitation of the creation, review, lifecycle management, and archiving of the electronic submissions.

Meeting eCTD standards forces site leaders and others to “modularize” their content, Nichols says. “The bottom line is it’s a pain in the neck because it’s wildly different from the way you did an [Investigational New Drug (IND) application] before,” he explains.

Free for ACRP Members – Nichols will present a Webinar on September 12 entitled “INDs and the eCTD Submission Mandate.” This Webinar will explore the FDA mandate for all submissions (including commercial INDs) to be provided in the eCTD (electronic Common Technical Document) format. View Webinar Details

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Nichols offers some tips to executing a strong compliance plan. “Your FDA reviewer wants to move around in your submission as easily and quickly as possible,” he notes. Here are a few ideas to reach that important goal:

  • Use hyperlinks within your document to jump to related key information, but DO NOT add hyperlinks to external sources, such as websites and e-mail addresses.
  • Ensure your PDF documents have bookmarks (documents over four pages MUST be bookmarked).
  • Ensure your PDF documents comply with FDA technical requirements, for instance in terms of font embedding, bookmark inherit zoom, and allowed fonts.

In addition to keeping yourself on the right side of FDA regulators, submitting eCTDs properly has multiple benefits. For starters, INDs tend to be approved more quickly. It also helps ease workflow and workload.

“It kind of flattens out the work,” Nichols says. “Instead of sending a big pile up front or sending a pile that grows…you’re only sending what’s new or different.”

Author: Michael Causey