eCTD Basics and Getting Started
The Electronic Common Technical Document (eCTD) is CDER/CBER’s standard format for electronic regulatory submissions. The FDA would like to work closely with people who plan to provide a submission using the eCTD specifications and we offer the following steps to help smooth the process.
- Review the information on the eCTD web page
- View recent eCTD presentations by FDA staff
- Refer to the Comprehensive Table of Contents Headings and Hierarchy (PDF) for information on document location, and for a regulatory and CFR mapping to the CTD (see page 12)
- Plan and prepare early for electronic submission and obtain clarification from firstname.lastname@example.org or the appropriate Review Division in advance.
- Build and maintain a knowledge base:
- Understand the electronic submission process
- Review the most recent eCTD presentations by FDA staff so you’re aware of current recommendations and common issues
- Be knowledgeable about what FDA resources (websites, guidance documents, etc.) are available and what email addresses should be used for obtaining information and clarification
- Learn where and how submission information is referenced in an eCTD
- Stay informed of existing, new and updated eCTD related information
- Ensure searchable PDF format is used that is compliant with the ICH M4 Granularity Annex and FDA PDF Specification and ensure documents and files provided by CROs also are compliant with Specifications.
- Plan accordingly and avoid rushing when submitting to help avoid mistakes. What may seem like a small error can have big implications (such as a wrong digit in your application number)
- Utilize a procedure to verify that your submission is complete and accurate
- Use the Electronic Submissions Gateway and FDA fillable forms with digital signatures which allows automated processing to quickly and efficiently route your submission to the review teams.