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 […]