SFDA issued the updated “Clinical Considerations for Vaccines” guideline – Version 2.0 clarifies regulatory expectations for clinical development and major variations of human vaccines.

🔍 What’s new:

• Sets specific NDA requirements for novel vaccines, vaccines with known antigens developed by new manufacturers, and combination vaccines, including immune interference assessment.
• New General Safety Considerations, including standardized AE/SAE collection and a generally accepted minimum exposure of 3,000 subjects.
• Updated Correlates of Protection (ICP) table covering 19 vaccines with defined assays and immune thresholds.
• Type II variation requirements, including bridging studies for age-group extensions.
• Mandatory GCP compliance and adherence to GCC data requirements.
• ِِThe active comparator vaccine in non-inferiority trials must be registered by SFDA or approved by a recognized SRA.

💡 Why it matters:

• The guidance clearly defines when superiority, non-inferiority, immune correlate–based evaluation, or bridging studies are required.
  
• Where established ICP thresholds exist, they may support immunogenicity-based evaluation, as applicable.
• Comparator eligibility and pre-specified non-inferiority margins are key to regulatory acceptance.

📌 How ReguLinked can support you:

• Reviewing and confirming that the CTD dossier is complete and aligned with submission requirements, without compliance gaps.
• Verifying overall regulatory compliance of the clinical studies, including GCP documentation, comparator eligibility, and required safety exposure.

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📎 Official Guideline: Clinical Considerations for Vaccines V 2

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