FDA Module 1 Update Set for Q4 2014
The biggest change in the history of eCTD is one step closer to implementation.
According to a notice posted this week on its website, the US FDA will be able to receive submissions using the new Module 1 specifications in the 4th Quarter of 2014. Industry will be given 30 days’ advance notice.
The long-awaited update to the eCTD’s administrative section is designed to:
- Reflect regulatory changes
- Provide clarification of business rules for submission processing and review
- Refine the characterization of promotional marketing materials and advertising material
- Facilitate automated processing of submissions
In conjunction with the announcement of a revised timeline for Module 1, the FDA published final versions of relevant support documents and specifications.
eCTD M1 Documents:
- Comprehensive Table of Contents Headings and Hierarchy Version 2.3
- The eCTD Backbone Files Specification for Module 1 Version 2.3
- Example Submissions using the eCTD Backbone Files Specification for Module 1 Version 1.3
eCTD M1 Supportive Files:
Another item of note in the release of information on the implementation of the new Module 1 is the redesignation of ‘Prereview of television advertisements’ from 503B to 503C (21 USC 353c). The eCTD heading “126.96.36.199. Promotional materials submitted pursuant to section 503B” is being changed to “188.8.131.52 Pre-dissemination review of television ads.”