Jan. 7, 2008 | Procrastinators, take heed. If you act now, you may be able to meet the FDA’s new eCTD mandate for regulatory submissions by mid-year. It will take at least that long to get an electronic system installed, load it with the appropriate documents, and make decisions about the use and ownership of the metadata, says Warren Perry, compliance advisor for Qumas, a Cork, Ireland-based document management company.

The FDA has been telling companies “in no uncertain terms” that the common technical document (CTD) is the only acceptable submissions format, says Perry. “[Industry] can’t do NDAs [new drug applications] or INDs [investigational new drug applications] anymore. The only choice left is whether to do an electronic or paper CTD.”

For companies that already do any kind of electronic submission, the transition to the eCTD guidelines is “not a big deal,” says Perry. “They already have documents in an electronic format, audit trails, and electronic signatures. They understand how to manage documents according to [CFR] Part 11 standards.”

The FDA has made it clear that paper-based submissions “will not get the kind of attention needed” by business-savvy organizations, adds Perry. Agency review time for paper submissions is usually six months longer than for electronic ones. “A year from now, I expect review time [for paper submissions] will be eight to ten months longer.” If daily sales of a drug are projected at half a million dollars, that’s a lot of lost money.

“We’re not talking about the advantages and disadvantages of electronic submissions with companies anymore,” says Perry. “Their first or second question is, ‘How soon can you have us up and running?’ ” The answer is, never soon enough. “We can install and validate a system [DocCompliance] in as little as 30 days, but there’s a huge amount of work that has to be done by people in the company familiar with the documents themselves.”

Companies not only have to inventory potentially tens of thousands of documents, says Perry. They have to get current versions of each one. “There may be five different versions of a document on five different scientists’ laptops, and they may all think they have the current, correct [one].”

Other major document management vendors, notably First Consulting Group and MasterControl, are presumably also fielding a fresh wave of inquiries about eCTD. Companies such as ISI and Liquent that sell publishing systems for both paper and electronic submissions may also see an increase in business.

One Qumas “differentiator” is a pre-configured package with all the components needed to publish an eCTD. The kit was released in June and has had “great traction” with smaller companies.

For pharmaceutical companies, making the switch from paper to electronic submissions “drastically decreases” cycle times of correspondence with the FDA, says Perry. The eCTD mandate will also “help the FDA move toward its risk map regulatory strategy faster because everybody at all times will have the entire history of a drug in front of them.” Approved drugs also will be more carefully monitored for adverse events during the post-marketing phase.

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This article first appeared in Bio-IT World’s eCliniqua newsletter. Click here for a free subscription to eCliniqua.