FDA Implementation of eCTD Module 1 Update Scheduled 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.

 

http://theectdsummit.com/2014/02/fda-implementation-of-ectd-module-1-update-scheduled-for-q4-2014/