Posted 03 August 2012
By Alexander Gaffney
The US Food and Drug Administration (FDA) has announced the release of "major updates" to Module 1 of the electronic common technical documents (eCTD), used to supplement all eCTD submissions in the US with specific information required by FDA.
The two documents, The eCTD Backbone Files Specification for Module 1, version 2.0 and Comprehensive Table of Contents Headings and Hierarchy, version 2.0., are available on FDA's website along with other supporting technical files.
In its 3 August Federal Register statement, FDA said the documents represent "major updates" to Module 1 of the eCTD, which contains summary information specific to each regional regulatory authority-in this case, FDA. Additional Modules-2, 3, 4 and 5-are standardized across regions that accept the eCTD.
Changes to Module 1
FDA said the documents contain a number of changes, including:
- "Allow submission of promotional label and advertising materials to CDER in eCTD format."
- "Provide for processing of grouped submissions (e.g., a supplement that can be applied to more than one new drug application or biologics license application)."
- "Provide detailed contact information so that companies can specify points of contact to discuss technical matters that may arise with a submission."
- "Clarify headings."
- "Use attributes in place of certain headings to provide flexibility for future changes without revising the specification itself."
The agency said while the documents are released to the public, it is not yet prepared to accept submissions using the new format because both it and its vendors need time to update their software to be able to accept submissions. FDA said it expects to be able to receive submissions by September 2013, but will provide 30 days advance notice to industry when it can provide a "firm date."
eCTD submissions are used by signatory parties to the International Conference on Harmonization (ICH), and both FDA's Centers for Biologics Evaluation and Research (CBER) and Drug Evaluation and Research (CDER) accept the applications. FDA notes that, "The majority of new electronic submissions are now received in eCTD format," because of its ease of use for regulators and industry alike.
Federal Register - Documents to Support Submission of an Electronic Common Technical Document; Availability