SFDA publishes Version 4.0 of Data Requirements for Human Drug Submissions (August 2025)

🔍 What’s new:
The SFDA’s updated “Data Requirements for Human Drugs Submission” (Version 4.0) refines dossier expectations across all CTD modules, with key enhancements including:

• Well-Established Use (WEU) Applications Pathway added as a new regulatory pathway (for substances used >10 years with established efficacy/safety)
• Impurities: expanded to cover degradation products, solvents, elemental impurities, and mandatory nitrosamine risk assessment (drug substance & drug product)
• Updated Analytical Procedures to include Detailed documentation of calculation formulas and methods, including the use of raw data and scientific justification for any correction factors.
• Update Regional Information section to include Specific requirements for biosimilars (comparative quality exercise) and advanced therapy medicinal products (shipping validation studies).

💡 Why it matters:
These updates reflect SFDA’s shift toward globally harmonized, data-driven submissions—underscoring a commitment to integrity, transparency, and efficient reviews. Companies that adapt early will benefit from smoother dossier validation, fewer authority queries, and faster time-to-market across

📌 How ReguLinked can support you:

• Advise on the optimal pathway (NCE, Generic, Biosimilar, WEU).
• Gap analysis of your current dossiers vs. Version 4.0 eCTD requirements
• Assemble full dossiers with QC checks, correct XML backbone, and SFDA-compliant submission.
• Act as a local partner for exemptions, prior advice, and smooth SFDA communication.

📨 Planning your next human drug submission? Partner with ReguLinked to ensure your data package meets Version 4.0 standards—and secures rapid SFDA approval.

📧 consultation@regulinked.com | 🌐 www.regulinked.com

📎 Access the official SFDA guideline here:
🔗 Data Requirements for Human Drugs Submission – Version 4.0 (PDF)
🔗 SFDA Official Website – Human Drugs Section

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