Definition
eCTD (Electronic Common Technical Document) is the mandatory electronic format specification for pharmaceutical regulatory submissions. It defines how CTD content should be structured and submitted electronically to regulatory agencies.
How eCTD Works
eCTD packages CTD content into an electronic format using XML backbone files and PDF documents. The structure enables efficient review, lifecycle management, and archival of regulatory submissions.
eCTD Specifications
| Element | Description |
|---|---|
| XML Backbone | Defines document structure and metadata |
| PDF Documents | Content files with hyperlinks and bookmarks |
| Lifecycle Operations | Add, replace, delete, or append documents |
| Submission Sequence | Numbered sequences tracking submission history |
eCTD Submission Process
- Prepare: Author documents in CTD structure
- Compile: Build eCTD using publishing software
- Validate: Check against FDA technical specifications
- Transmit: Send via FDA Electronic Submissions Gateway
- Acknowledge: FDA confirms receipt and technical compliance
FDA eCTD Requirements
| Application Type | eCTD Required |
|---|---|
| NDA | Yes |
| ANDA | Yes |
| BLA | Yes |
| IND | Recommended |
| Amendments/Supplements | Yes |
Why BD Teams Track eCTD
For business development professionals, eCTD capability affects partnerships:
- Deal Implication: eCTD publishing capability is essential for US regulatory strategy
- Due Diligence Focus: Verify regulatory submission infrastructure and track record
- Opportunity Signal: Strong eCTD capabilities indicate regulatory maturity