Electronic Common Technical Document

With ever evolving regulations, USAMRMC must continually reassess standards, processes, and technology to be operationally positioned to meet emerging FDA requirements.

In the US, with the reauthorization and update of the Prescription Drug User Fee Act (PDUFA), it is now a requirement that submissions to the FDA use the electronic Common Technical Document (eCTD) format. The eCTD’s paper-based predecessor, the Common Technical Document (CTD) was developed by the International Conference on Harmonisation (ICH) in 2000; with the electronic version following in 2003. The electronic format is designed to make regulatory submissions easier and more efficient. It provides a common global standard to electronically submit quality, safety, and efficacy information required for the approval of a new drug to regulatory agencies.

The eIT PMO’s eCTD system was implemented in Production in August 2013. The FDA 21 CFR Part 11 compliant product is specifically intended for use by USAMMDA’s Division of Regulated Activities and Compliance (DRAC), for preparation and life cycle maintenance of regulatory submissions originating from OTSG/Army sponsored investigational product development.

The eCTD system consists of two major parts; a Publisher which creates the submission packages, and a Viewer which allows users to view the submission packages. Both the Publisher and the Viewer components of eCTD interface with the eIT PMO Electronic Document Management System (EDMS). Documents managed within EDMS are available for direct inclusion into the electronic regulatory filings created using the eCTD Publisher. The system represents the final IT component needed for complete in-house capability to electronically capture and submit regulatory documentation to the FDA.

In September 2013, USAMMDA DRAC submitted its first in-house developed, all electronic Investigational New Drug (IND) application in the eCTD format to the FDA. Prior to use of the system, it was necessary to outsource this type of work. USAMRMC is now able to produce FDA mandated eCTD formatted submissions cheaper than outsourcing—as much as 40%—and retain complete control of the regulatory documents.

The eCTD system is managed by the eIT PMO and is integrated into the eIT PMO Common IT Infrastructure.

For more information please contact us at usarmy.detrick.medcom-usamrmc.other.eit-pmo@mail.mil.