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As the Saudi Food and Drug Authority (SFDA) sharpens its Regulatory Affairs oversight in 2025, compliance with SFDA eCTD Module 1 guidance 2025 has become a cornerstone for the successful registration and maintenance of medicinal products in the Kingdom of Saudi Arabia (KSA).
For professionals in Regultory publishing and Regulatory submissions, understanding and implementing KSA-specific enhancements to Module 1 is crucial to avoid submission failures, delays, or non-compliance penalties.
What’s New in SFDA eCTD Module 1 – 2025 Updates
1. Revised Folder Structure and XML Schema
SFDA has released eCTD Specification Version 2.1.1 (Q1 2025), enforcing:
- New mandatory folder hierarchies
- Updated XML DTD schema v3.3
- Precise file naming conventions to prevent validation errors
Submissions must follow the SFDA eCTD Module 1 guidelines 2025 to ensure proper lifecycle tracking and review efficiency.
2. Updated National Application Form (2025 Edition)
- Now required in both editable (Word) and signed (PDF) formats
- Arabic-English bilingual form with updated fields for QPPV, legal representative, and manufacturer details
Failure to use the 2025 version may result in automatic rejection at the gatekeeping stage.
3. Enhanced Pharmacovigilance Documentation
In addition to the LPO (Local Pharmacovigilance Officer) Appointment Letter, SFDA now mandates:
- Contact details of the LPO
- Confirmation that the LPO is based in KSA
- PSMF location declaration with global access statement
These changes are a core part of SFDA drug submission rules 2025 and directly impact Saudi Arabia eCTD submission requirements.
4. RMP Summary Requirements
As of January 2025:
- All new applications (and major variations) must include an RMP Summary
- Must align with the latest SFDA risk minimization guidance
- RMP must be referenced in Module 1.8.2 and supported with periodic updates as needed
This is among the notable Saudi FDA eCTD changes now influencing submission strategy.
5. Mandatory Technical Validation and Publishing Compliance
- Only submissions published using SFDA-approved eCTD tools are accepted
- Must include:
- Validation report
- Hyperlinked and bookmarked PDFs
- PDFs must be text-searchable (OCR-enabled) and limited to PDF v1.4–v1.7
- No image-only scans unless justified in a cover letter
SFDA eCTD Module 1 Compliance Checklist – 2025 Edition
| Requirement | Status |
|---|---|
| ✔️ eCTD Sequence Initiated (0000, 0001, etc.) | ☐ |
| ✔️ Folder structure follows SFDA Specification v2.1.1 | ☐ |
| ✔️ National Application Form (2025 version, signed & editable) | ☐ |
| ✔️ Cover Letter (Arabic/English, signed) | ☐ |
| ✔️ Authorization Letter from Manufacturer (if applicable) | ☐ |
| ✔️ LPO Appointment Letter with in-KSA contact details | ☐ |
| ✔️ Risk Management Plan Summary (aligned with Module 1.8.2) | ☐ |
| ✔️ Validation Report included | ☐ |
| ✔️ Hyperlinked, bookmarked, OCR-enabled PDFs | ☐ |
| ✔️ Arabic-English labeling and Patient Information Leaflets | ☐ |
| ✔️ Patent Declaration (for herbal or non-NCE products) | ☐ |
| ✔️ PSMF Location Declaration | ☐ |
Key Pitfalls to Avoid
- Submitting outdated application forms or misnaming folders
- Omitting validation reports or submitting non-searchable PDFs
- Missing mandatory PV documentation or LPO appointment letters
- Failure to update eCTD lifecycle sequence and metadata
Each of these can lead to technical rejection or prolonged regulatory queries.
Need Support with SFDA eCTD Submissions?
Navigating SFDA’s evolving eCTD framework requires precision, local insight, and validated publishing tools. Our regulatory experts at Freyr support end-to-end dossier lifecycle management, from Module 1 compilation to post-approval variations—ensuring 100% compliance with the latest SFDA regulations.
Talk to our experts today to ensure your next submission is SFDA-ready from Day One.
