# Presentation: 210472

## eCTD Processing

- Gary M Gensinger, MBA
*Review Technology Staff*
- Center for Drug Evaluation and Research

## Overview

- Submissions 101
- Guidance
- Changes from eNDA Guidance
- Continuation of eNDA Guidance
- Tools
- Resources for the Reviewer
- References

## Submissions 101

- Send All Original Applications to the Central Document Room
- Send all amendment and supplement submissions containing electronic media  to the Central Document Room
- Send all paper-only amendment or supplement submission to the Division Document Room
- Misrouting causes delays and confusion

**Notes:**
Federal records act requires archival

Review aids must be prepared in accordance with the guidance and archived

Ensures quick processing

No Cumulative Table of Ontents

## Submissions 101

- All submissions are archived
- Any submission containing electronic media is considered an electronic submission
- Never send electronic submissions directly to a reviewer or project manager
- Send all submissions containing an electronic component to Central Document Room

**Notes:**
Federal records act requires archival

Review aids must be prepared in accordance with the guidance and archived

Ensures quick processing

No Cumulative Table of Ontents

## eCTD Guidance

- eCTD Guidance Publishes Soon
- eCTD Specifications Published (by end of DIA)
- Comprehensive Table of Contents(Headings and Hierarchy)
- Backbone File Specification for Module 1
- Backbone File Specification for Modules 2-5
- Study Tagging Files Specification
- Specifications Available On-Line
- http://www.fda.gov/cder/regulatory/ersr/default.htm
- Current eNDA Guidance remains available as an alternative to the eCTD

## eCTD Changes

- XML-based eCTD Backbone replaces PDF Tables of Content
- Increased document granularity in accordance with ICH eCTD agreements
- No requirement to submit technical sections or study reports in paper
- EVS processor performs rigid validation of backbone against DTD
- Requires strict adherence to specifications
- Do not add or modify leafs within the backbone
- Once a submission is sent in eCTD format all future submissions for the application should be in eCTD format
- Subfolders beyond the primary submission folder are no longer required

## What doesn’t change

- Data files submitted in SAS XPORT format
- Documents submitted in PDF Format
- Draft labeling submitted in MS Word
- Office 97 is current standard
- Office XP is being deployed

## Implementing the Guidance

- Initial Pilot Phase
- Contact CDER prior to generating submission
- Submission of fallback required, i.e., submission of paper or a PDF based table of contents to permit review if submission is fatally flawed
- Review process and make adjustments
- Plan to accept  multiple submission types, e.g.,  IND, NDA, Amendments, Annual Reports...

## eCTD Related Tools

## Submission Processing Tool

- EVS Processing Tool
- Validates presence of required files
- Validates eCTD Backbone against DTD
- Validates location of content referenced in eCTD Backbone.
- Makes submission available for viewer
- Adherence to the eCTD specification is critical

## Submission Review Tools

- EVS Viewer
- Provides reviewers with direct access to submissions
- Provides submission based view of applications
- Provides a module based view of submissions
- Provides a “Cumulative Table of Contents” view of applications
- Provides download capability for off-line reviewing

## Availability of Tools For Industry

- FDA will make processing and review tools available to industry
- Download free from FDA web site
- Tools provided on an as-is basis
- No support from FDA will be provided
- Anticipate 3rd party developers creating tools to support generation and validation of submission prior to FDA submission

## Future eSubmission Direction

- Secure e-mail transmission of eCTD submission
- Digital signatures for forms requiring signature
- Size limitations due to e-mail restrictions
- Digital signing of physical media
- Permits filing of electronically signed forms normally requiring physical signature

## Resources for the Reviewer 

- Reviewer Training
- NEST and NEDAT
- JMP
- Just-In-Time
- Over-the-Shoulder
- Office of Information Management – Review Technology
- Pre-NDA Support
- OIM Attendance at pre-NDA Meetings
- Consultation on eSubmission Issues
- CTD and eCTD Subject Matter Experts

## References

**CDER Contact for information on CTD submissions**
- ctd@cder.fda.gov
**CDER Contact for information on eCTD submissions**
- eSub@cder.fda.gov
**Electronic Regulatory Submissions and Review** website
- http://www.fda.gov/cder/regulatory/ersr/default.htm
**International Conference on Harmonization**
- http://www.ich.org