RegulinkedSFDA issues “Good Review Practices (GRevPs)” Guideline Version 1.0
🔍 What’s new:
The guideline establishes a structured, transparent framework for how SFDA reviews medicinal product dossiers and manages review workflows.
Key elements include:
• Defined Good Review Practices (GRevPs) and Good Review Management Principles (GRMPs) to standardize review quality and decision-making.
• Guidance on communications during review (pre-submission interactions, information requests, and stakeholder engagement).
• Clear expectations for review personnel (roles, qualifications, training, and use of external experts).
💡 Why it matters:
GRevPs bring SFDA review practices closer to international best practice—improving transparency, consistency, and predictability for applicants and helping reduce avoidable review delays. For sponsors, this means clearer expectations on dossier format, completeness, and the review lifecycle.
📌 How ReguLinked can support you:
• Pre-submission readiness: gap assessment against GRevPs, improved dossier quality, and reviewer-focused briefing dossiers.
• Regulatory training & coaching: workshop for RA teams on GRevP principles, reviewer expectations, and effective communication with SFDA.
• Strategic planning: optimize submission timing, lifecycle planning, and reliance/abbreviated pathways where applicable.
• End-to-end services: eCTD publishing, Module-specific QC, labelling/artwork checks, and liaison support during the review cycle.
📨 Planning a submission or want to reduce your current review risk? Let ReguLinked help you align your dossiers and review strategy with SFDA’s GRevPs—so your files are reviewer-ready and your timetables are realistic.
📧 consultation@regulinked.com
📧 BD@regulinked.com
📎 Access the official SFDA guideline & source:
🔗 Good Review Practices Guideline (PDF).
#SFDA #GRevPs #GoodReviewPractices #RegulatoryAffairs #DossierQuality #eCTD #MarketAccess #Pharma #KSA #GCC #RegulatoryStrategy #ReguLinked
