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This updated guideline provides comprehensive direction on registration and variation applications for new chemical entities and biologics (human and veterinary medicines) through the Verification and Abridged pathways, streamlining regulatory approvals for products already approved by key reference agencies such as FDA, EMA, and USDA. 🔍 What's new in Version 3.0: ✅ Updated Objective and Scope ✅ Addition of Sameness of Product" definition ✅ Inclusion of Variation Application Requirements and Procedures ✅ New Regulatory Notes for Variations ✅ Updated Appendix and Variation Application Forms The revised document aligns with SFDA's commitment to advancing regulatory efficiency, transparency, and harmonization with global best practices — a significant step toward supporting Vision 2030 in fostering an innovative, science-driven healthcare ecosystem. Click to get the full guide on adopting modern, rigorous toxicology assessments today: https://lnkd.in/gFWff9ED Visit us www.intoxlab.com"