Regulatory & Guideline Updates

Connecting people, advancing clinical value

MFDS Fast‑Track 2026: Navigating GIFT Korea, Priority Review & Conditional Approval

MFDS Fast‑Track 2026: Navigating GIFT Korea, Priority Review & Conditional Approval

2025/12/17
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Korea Clinical Trial Strategy After MFDS 2025 Reforms: Why Korea is Becoming a Strategic Hub

Korea Clinical Trial Strategy After MFDS 2025 Reforms: Why Korea is Becoming a Strategic Hub

2025/11/26
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2026 MFDS IND Approval Trends and Triple‑Agonist Clinical Trial Strategies in Korea

2026 MFDS IND Approval Trends and Triple‑Agonist Clinical Trial Strategies in Korea

2025/11/19
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MFDS 2025 New Drug ReviewWhat You Need to Know

Korea MFDS 2025 Drug Approval Reform: Faster Review Teams, Rolling Review and Updated Timelines

2025/09/26
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2025 Drug Safety Regulation Updates® A Complete Guide for Practitioners

2025 Korea Drug Safety Regulation Updates: A Complete Guide for Practitioners

2025/07/17
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