June 2014 Announced as Module 1 Implementation Date
The U.S. Food & Drug Administration has set a new target date for the implementation of a significant change to Module 1. As we had forecast earlier this summer, the FDA now estimates it will be able to receive submissions utilizing Module 1 Specifications 2.2 by June 2014.
Vendors of eCTD software and the FDA have nine months to prepare and make the appropriate updates which is an adequate and achievable timeline.
A notice posted Monday, August 26th on the Federal Register concluded – “FDA is not prepared at present to accept submissions utilizing this new version of the eCTD Backbone Files Specification for Module 1, version 2.2, because eCTD vendors need time to update their software to accommodate this information and because it will require software upgrades within the Agency,”… “FDA estimates it will be able to receive submissions utilizing Module 1 specifications 2.2 by June 2014, and will give 30 days advance notice to industry.”
GlobalSubmit is well along in the process of updating its software to reflect the Module 1 changes and has already begun testing with the FDA.
In conjunction with the new implementation date, the FDA has released final versions of four important documents:
- The eCTD Backbone Files Specification for Module 1, Version 2.2
- The Comprehensive Table of Contents Headings and Hierarchy, Version 2.2
- Specifications for eCTD Validation Criteria, Version 3.0
- Example Submissions using eCTD Backbone Files Specification for Module 1, Version 1.2
The update to Module 1 is designed to incorporate recent regulatory changes, provide clarification of business rules for submission processing and review, refine the characterization of promotional marketing and advertising material, and facilitate automated processing of submissions.