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.