The US Food and Drug Administration (FDA) has issued a new document outlining the process by which sponsors of drug applications should use the electronic Common Technical Document (eCTD), and in particular its file format types.

Background

The eCTD is a standard developed and implemented by the International Conference on Harmonisation (ICH), an international regulatory harmonization group focused on pharmaceutical and biological products. The standard is meant to streamline the application process for regulatory dossiers, allowing sponsors to more easily prepare a submission for regulatory review in the EU, US and Japan. 

Modules 2, 3, 4 and 5 of the eCTD are common to all regions, while module 1, the regional administrative information module, is not.

Since 2008, FDA has expressed its preference for the eCTD, and a recently-released draft guidance document explains that the agency will soon require sponsors to submit their applications in the form of an eCTD, raising numerous concerns among industry. The agency has also recently made changes to permit the cross-reference of medical devices in the eCTD format-a rarity given the document's focus on pharmaceuticals.

Changes

Importantly, the eCTD standard has numerous versions, all of which are built on an Extensible Markup Language (XML) backbone, allowing for high degrees of customization. While this confers many advantages, it also means sponsors are limited in what files they may include with an application.

The good news: Sponsors will soon be able to utilize more formats than ever before.

"Previously, formats for files contained within eCTD submissions were limited to those specified in the 'eCTD Backbone File Specification for Modules 2 through 5.3.2.2.,'" FDA explained. "However, as review tools and methods have changed and with the acceptance of advertising and promotional labeling in the eCTD format, it has become necessary to expand the range of file types accepted."

In particular, that applies to images, which are useful in portraying various types of information.

"Documents should be provided in PDF searchable format," it explained. "Images (e.g., BMP, JPG, GIF, PNG) should be rendered into PDF format and retain searchable text whenever possible."

Additional details are provided within FDA's document, which may be found here.