Posted 14 May 2014
By Alexander Gaffney, RAC
The US Food and Drug Administration (FDA) has released revised and final versions of four documents intended to facilitate the submission of drug applications using the electronic common technical document (eCTD), a harmonized electronic submission standard used in the US, EU and Japan.
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 as the result of the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, FDA will soon require all sponsors to submit their applications in the form of an eCTD. (Read more)
New eCTD Changes
Now FDA has announced the release of new backbone files-the eCTD uses an XML-based backbone-it says it will be able to receive in the coming months.
The four new backbone files are:
- The Comprehensive Table of Contents Headings and Hierarchy (version 2.3)
- Specifications for eCTD Validation Criteria (version 3.1)
- Example Submissions using eCTD Backbone Files Specification for Module 1 (version 1.3)
- The eCTD Backbone Files Specification for Module 1 (version 2.3) (which includes the U.S. regional document type definition (DTD), version 3.3)
FDA said in a Federal Register posting that the updates will make the standards compliant with regulatory changes, clarify the review and processing of submissions, facilitate automatic processing, and "refine the characterization of promotional marketing and advertising material." (More Here)
Software vendors, FDA noted, will need time to update their software to accommodate the new versions of the eCTD modules. As such, the agency will not be accepting the new format until the end of 2014, and plans to give at least 30 days' notice of the pending changes to industry.
The updated documents will be available on FDA's eCTD webpage.
Federal Register posting