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 | ニュース | ミクスOnline) released by Mixonline on March 29, 2025, the Pharmaceuticals and Medical Devices Agency (PMDA) has notified relevant industry groups that documentation submitted for clinical trial consultations for adult drug development must now include a statement on the presence or absence of pediatric drug […]

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.) released by Astellas Pharma on Feb/05/2025, they have submitted a manufacturing and marketing approval application in Japan for avacincaptad pegol (ACP), branded as IZERVAY, targeting geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Notably, this application is under Japan’s […]