2026.04.13
PMDA Early Consideration on Clinical Trials with a Limited Number of Subjects: Key Considerations for Drug Development in Japan
Introduction to Small Sample Clinical TrialsAccording to the notification issued by the Pharmaceuticals and Me […]
2026.02.26
Japan Enhances Global Clinical Trial Access Through One-Stop Window and PMDA Collaboration
Introduction to the New Clinical Trial Initiative According to the official notification issued by Japan’s Min […]
2025.04.08
Japan’s New Requirement for Pediatric Drug Development Plans in PMDA Consultations
Introduction to Regulatory UpdateAccording to the news (PMDA 成人対象の治験相談でも「小児用医薬品の開発計画の有無を資料に記載」日薬連等に留意事項通知 | ニュ […]
2025.02.27
Astellas Seeks Conditional Approval in Japan for Geographic Atrophy Treatment Without Japanese Patient Data
Introduction to Astellas’ Pioneering Regulatory Submission According to the news (News | Astellas Pharma Inc.) […]