Why a Submission Checklist Matters
Regulatory Compliance: Global authorities like the FDA, EMA, MHRA, and PMDA enforce strict technical specifications. A checklist ensures you meet metadata, structure, and lifecycle requirements.
Error Prevention: Missing hyperlinks, incorrect granularity, and naming mismatches are common causes of rejection. A good checklist helps catch these early.
Time & Cost Efficiency: Finding errors after submission means rolling out new eCTD sequences—wasting time and money.
Consistency: Good checklist discipline promotes standardisation across your organisation’s submissions.
About e-CTD Plus
e-CTD Plus, developed by Topia Pharma Intelligence, is a leading platform for eCTD publishing services and regulatory submission support. It centralizes document management, automates validation, and streamlines workflows with roles like “Doer,” “Reviewer,” and “Publisher”. Notable features include:
- Automated technical validation (latest global criteria)
- Automated PDF optimization with links, bookmarks, and compliance
- Structured workflows and audit trail reporting
These capabilities directly support each checklist element outlined below.
Comprehensive eCTD Submission Checklist
| Area | What to Check | Why It Matters |
|---|---|---|
| Module Structure | Modules 1 to 5 are properly organized within the XML structure. | Ensures regulatory bodies can navigate content easily. |
| Filename & Titles | Titles & filenames meet ICH and agency rules. | Prevents validation errors and misrouting. |
| Document Granularity | Split documents logically at the leaf level. | Supports traceability & easier updates. |
| Metadata Accuracy | XML tags, e.g., |
Key to submission integrity and lifecycle control. |
| Lifecycle Management | Previous sequences superseded correctly. | Maintains version history; prevents mix-ups. |
| Hyperlinks & Bookmarks | All internal links work, and bookmarks are present. | Essential for reviewer navigation; often validated. |
| PDF Optimization | PDF/A compliance, file size limits met. | Ensures acceptable downloads; avoids technical rejections. |
| Validation Report | All errors resolved pre-submission. | Avoids rejections and resubmissions. |
| Audit Trail | Reviewer and Publisher sign-offs captured. | Documentation of accountability. |
| Final Review | Manual QC after automated checks. | Catch naming/contextual issues that automation misses. |
| Backup | Archive original XML, PDFs, and validation logs. | Essential for audit, retrieval, and follow-up sequences. |
| Submission Portal | Ensure the gateway (FDA ESG, EMA CESP) is ready. | Portal issues can halt delivery even after the dossier is ready. |
How e-CTD Plus Helps You Check All Boxes
The automated validation module flags XML structure, metadata, hyperlink, and granularity issues before they reach the portal.
PDF optimizer ensures compliance with hyperlinking and bookmarks standards with one click.
Structured workflows and built-in reporting support audit trails and sign-offs for each review stage.
As a result, eCTD Plus users experience fewer submission errors, faster approvals, and stronger regulatory compliance.
(Interested in learning more? Explore our eCTD publishing services or regulatory submission support pages.)
Frequently Asked Questions (FAQs)
A checklist ensures you don’t miss critical steps—like validation or hyperlink checks—avoiding costly rejections and delays. It provides a consistent, compliance-driven workflow. Learn more about eCTD requirements on e-CTD Plus’s Beginner’s Guide.
Document granularity means splitting files at logical, discrete sections (e.g., PDF per study report), enhancing traceability and simplifying lifecycle updates.
Each new eCTD uses a sequence that updates or supersedes previous files. Proper lifecycle control ensures version control and prevents mix-ups.
Yes. eCTD Plus includes automated validation tools to check XML structure, metadata, hyperlinks, and PDF compliance, ensuring full readiness before submission.
Check for PDF/A compliance, embedded bookmarks and hyperlinks, and acceptable file size. eCTD Plus automates this process to meet agency-specific standards.
Reference Links
- ICH M2 EWG Electronic Common Technical Document Specification
- M2 Recommendations & Technical References
- M4: The Common Technical Document
- Multidisciplinary Guidelines
- eCTD 4.0: What's new in the Granularity Update?
- ICH electronic Common Technical Document - eCTD v4.0
- eCTD Technical Conformance Guide
- FDA: Electronic Common Technical Document (eCTD)
- EMA eCTD Guidance Document v1.0
- FDA ESG (Electronic Submission Gateway) Webpage
- eCTD Plus Beginner’s Guide
