Industry Wants to See eCTD Benefit at FDA, Expert Says

Adoption of the electronic common technical document (eCTD) is growing quickly as firms recognize that it makes their lives easier to file something once for different regulatory bodies, but industry may not fully embrace the technology until it is convinced that it will speed esubmissions to the FDA, expert Kim Nitahara told PIR last week.

“There’s an enormous interest globally in eCTD,” said Nitahara, a long-time leader in the field and CEO of Meta Solutions. Larger companies are adopting it more quickly than smaller firms with fewer financial and personnel resources, he noted, but even companies that focus on one region of the globe are finding it valuable because many drugs and devices are sold worldwide today. “But if industry doesn’t see the benefit of using eCTD at the FDA,” it won’t move so quickly to adopt it, Nitahara said.

The agency recognizes this, and that’s a big part of the recent push it has made at public forums advocating eCTD and esubmissions, he noted. For example, Nitahara will be hosting a Drug Information Association summit in Philadelphia next month where FDA officials will discuss in greater detail how regulated firms are using eCTD and how they can work more effectively with the agency to ramp up efforts in that direction.

Nitahara hopes agency officials will also provide more details about its imminent revision of 21 CFR Part 11 at the Philadelphia gathering. However, sources close to the agency have told PIR that the revised Part 11 may not go public until April. “It’s going slower internally than the agency had expected,” one consultant said FDA officials told her.

Meanwhile, the FDA is intent on helping firms improve their eCTD efforts and demonstrate that the agency – and all of its reviewers – is actively encouraging its use. At a recent CDER online Town Hall meeting, FDA staff expressed some surprise when told by several questioners that they had felt some resistance to the format from their individual inspector.

“I’m not sure how much advantage industry is seeing from the FDA [right now] in terms of speed or quality of review” when using eCTD versus paper, Nitahara noted. — Michael Causey