Getting eCTD Submissions Right

Pharma IQ

While technology has undoubtedly had an impact on the techniques pharmaceutical firms use to develop new drugs, the digital revolution has also had a major effect on how they meet the number of regulations which exist within the industry. A key way that computing has influenced the sector is through the use of the electronic common technical document - or eCTD.

Now viewed as an accepted way for drug development companies to submit applications for regulatory approval, the systems are particularly popular with the US Food and Drug dministration (FDA), which has regarded them as astandardised format for the past two years. Their prominence is set to rise in Europe in the coming months, as authorities across the continent increasingly adopt the concept.

The growing influence means that businesses need to ensure they are able to make use of eCTDs in the correct manner, but Adam Sherlock, Managing Director of ISI Europe, recently outlined in a column for that this can occasionally be difficult to do. He explained: "The eCTD, while a valuable way for companies to manage their regulatory lifecycle, brings with it additional time and financial burdens."

Mr Sherlock explained he has seen anecdotal evidence that many firms face some issues in relation to moving from "laboured, disparate systems" to ones which "allow more seamless access to critical information for preparing regulatory submissions in this new paradigm".

"Many have been taking stock of their expertise and assessing what is a core competency and what tasks, while critical, don't bring competitive advantage," he added.

Getting the correct systems in place to deal with eCTDs may prove to be just one of several challenges for companies, however. Another key issue for firms to address is how they can make the submissions as suitable for regulators as possible. Evan Richardson, director of regulatory operations at Cato Research, recently outlined some advice for firms facing up to this task.

In a column for Pharmaceutical Pro, in which he describes the best way to meet the FDA's guidelines for eCTD submissions, he explained that formatting can be key to getting documentation reviewed quickly.

"The agency now employs software that can read these forms and automatically route your submission to the appropriate review division," he explained on the website. "If you provide a scanned copy of a form, your submission is 'kicked-out' of the automated processing system and must wait for manual processing."

Like all documentation, companies could benefit from breaking down the contents of eCTDs in order to make it easier for readers to digest. However, Mr Richardson called on businesses to exercise some caution over the issue, stating that it should not be done just for the sake of it.

"Before breaking a large document into several smaller documents, consider if doing so supports the goal," he outlined. "Submitting a multitude of one-pagedocuments will frustrate your reviewers and make it more difficult for them to review your application."

A final piece of advice from Mr Richardson was that those in charge of formulating eCTD submissions have to ensure they keep a good distance from it and are able to view it through the eyes of a member of the FDA. He added that issues to look out for include whether formatting is consistent throughout and if the publication can be easily navigated.

With the use of eCTD submissions growing in pharmaceutical sectors across the globe, a number of firms may benefit from addressing the issues raised by the expert. While it appears that introducing the platforms may not always be a seamless process, it seems the quicker companies get to grips with it, the better. By embracing the area fully, firms may be able to make their operations more efficient while saving time dealing with a large amount of paperwork in the process.