##  [Your 2025 Guide & Checklist to SFDA’s New eCTD Module 1 Rules](/index%2ephp/blog/your-2025-guide-checklist-to-sfdas-new-ectd-module-1-rules) 

    May 27, 2025 

  ![Your 2025 Guide & Checklist to SFDA’s New eCTD Module 1 Rules]()

2 min read 

- [Medicinal Products](/index%2ephp/blog-main-categories/medicinal-products)
- [Regulatory Affairs](/index%2ephp/blog-main-categories/regulatory-affairs)





 

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**](https://saudiarabia.freyrsolutions.com/contact-us) to ensure your next submission is SFDA-ready from Day One.