SFDA issues updated “Verification & Abridged Pathways” Guideline (Version 3.0 — Issued October 2025 | Effective 20 January 2026)

🔍 What’s new:

• Expanded scope to include Type II variations for NCEs and biologics (human & veterinary)
• New definition of “Sameness of product” — requiring identical essential characteristics (composition, strength, indication, manufacturing, etc.)

💡 Why it matters:
This update significantly strengthens accelerated registrations and now supports post-approval lifecycle alignment with reference agencies — helping companies:

✅ Reduce time-to-market
✅ Maintain global dossier & change synchronization
✅ Streamline Type II variation approvals

⏱️ Faster Regulatory Timelines:
• Verification: ~30 working days
• Abridged: ~60 working days
(subject to validation & eligibility)

📌 How ReguLinked can support you:

• Pathway Eligibility Assessment: Screen target products against all criteria (e.g., 2-year approval window, manufacturing location, need for stringent assessment) to determine the optimal registration pathway (Verification, Abridged, or Standard).

• Dossier Mapping & Compilation: Ensure compliance by mapping Modules 2-5 to be identical to the reference agency’s eCTD/vNees submission and accurately compiling the crucial Module 1 documentation.

📨 Planning to leverage US FDA / EMA approvals for faster Saudi market access?

Let ReguLinked accelerate your submissions with a fully compliant verification/abridged strategy.

📧 bd@regulinked.com 🌐 www.regulinked.com

Book your complimentary consultation today

📎 Official Source:
Saudi Food and Drug Authority — Verification & Abridged Pathways (Version 3.0)

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