CDER Officials Urge Firms to Participate in FDA's eCTD Testing

Regulated life sciences firms that want to realize the speed and efficiency promised by electronic common technical document (eCTD) reporting should make use of the FDA's testing program, agency officials said last week at an online "Town Hall" meeting sponsored by the Drug Information Association.

One hurdle some companies have to get over is worrying too much about the content of their eCTD during the testing process. "The testing is not about the content," stressed Stephen Wilson, acting director of the Center for Drug Evaluation and Research's (CDER) Office of Business Process Support. The FDA does not review content during the testing, he said. "Common technical document" refers to an application format for submissions to CBER or CDER. An eCTD is the electronic version of that format.

Wilson outlined what companies need to do in order to produce a successful esubmission:

Review the eCTD specifications on the FDA website before sending; Contact the FDA at esubs@cder.fda.gov (mailto:esubs@cder.fda.gov) before creating an esubmission; Look at FDA samples online; Submit your own samples and then work with the FDA to identify technical glitches; and Resolve the glitches.

The FDA aims to have a test reviewed and sent back to the company within a week or two, but often can turn them around within a day or two, Wilson said at the Jan. 18 meeting.

An Agency Push

The FDA is "really pushing" for industry to move toward eCTD, said Randy Levin, CDER's director for health and regulatory data standards. He said that agency reviewers have been applying friendly "pressure and enthusiasm" for industry to submit more eCTDs.

But some audience members said they'd had trouble with individual reviewers who seemed to be clinging to the idea of paper submissions. Wilson expressed surprise, explaining that the agency has high-speed printers on-site, and reviewers can also print key portions of an eCTD. "It is like on-demand publishing," he said.

Still, the questions reflected some industry dissatisfaction with how some FDA reviewers are approaching eCTD and esubmissions (see next story).

More eCTDs will create their own momentum within the agency, Levin said, adding that reviewers tell him that once they get an esubmission, it is hard to go back to paper.

Another plus: Reviewers at FDA aren't likely to need much in the way of training for handling esubmissions, Wilson said. "My impression is they won't need a lot of training [because] esubs are self-evident," he said.

While the number of eCTD submissions to the agency is growing every day, Levin said some of those submissions did not follow the agency's specifications -- in particular, the agency has seen companies struggling with extensible markup language (XML) and study tagging, he said.

The International Conference on Harmonization developed the eCTD backbone files, written in XML, to replace the usual PDF table of contents because XML has more power to display data and information, according to the FDA. The FDA's October guidance on esubmissions applies to marketing applications (including abbreviated new drug applications, biologics license applications and new drug applications) and investigational new drugs and related submissions, such as drug master files, advertising material and promotional labeling. However, it does not apply to electronic submission of prelicense or preapproval inspection materials or applications for combination products.

To view the guidance, "Providing Regulatory Submissions in Electronic Format -- Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications," go to http://www.fda.gov/cder/guidance/6766fnl.htm (http://www.fda.gov/cder/guidance/6766fnl.htm). For esubmissions to CDER, go to http://www.fda.gov/cder/regulatory/ersr/ectd.htm (http://www.fda.gov/cder/regulatory/ersr/ectd.htm). -- Michael Causey