On May 15, 2014 the FDA released four revised final versions of “documents that support making regulatory submissions in electronic format using the electronic Common Technical Document (eCTD).” Specifically the FDA has issued revisions to documents intended to assist in the filing of regional specific information in Module I and ways to further standardize eCTD submission submitted to the FDA:
- The eCTD Backbone Files Specification for Module I;
- The Comprehensive Table of Contents Headings and Hierarchy;
- Specifications for eCTD Validation Criteria;
- and, Example Submissions using eCTD Backbone Files Specification for Module I.
The FDA is currently not able to accept submissions utilizing these new specifications but estimates it will be able to receive submissions in the last quarter of 2014 and will provide industry with 30 days notice before the implementation. Fortunately, this delay in implementation will also allow software developers time to update and implement the new specifications in their publishing programs.
The notice in the Federal Register can be accessed here: