Shunsuke Iwano/LinkedIn
Jun 23, 2026, 23:30
Shunsuke Iwano: PMDA Introduces Greater Flexibility for Pediatric Factor VIII and IX Development in Japan
Shunsuke Iwano, Representative Director and CEO, Head of Regulatory Affars Practice Japan at Eliquent Japan, Inc, shared on LinkedIn:
”PMDA has released a new Early Consideration on the clinical evaluation of Factor VIII and Factor IX products for pediatric congenital hemophilia in Japan.
Key takeaway: PMDA is introducing greater flexibility for pediatric rare disease development.
For hemophilia therapies:
- Patients aged 12 plus can generally be evaluated together with adults
- Under certain conditions, Japanese clinical trials in children under 12 may be waived by leveraging foreign pediatric data
This is an important step toward reducing development burden, minimizing unnecessary pediatric trials, and accelerating access to innovative therapies in Japan.
A meaningful signal that Japan is becoming more pragmatic in rare disease drug development.”
Stay updated with Hemostasis Today.
-
Sep 24, 2026, 06:52Gina Sado: Screening-Detected Atrial Fibrillation Carries High Risk of Heart Failure
-
Sep 24, 2026, 06:33Benjamin Vipler: Optimal Oral Anticoagulation Choice in Atrial Fibrillation and Advanced CKD
-
Sep 24, 2026, 06:08Christopher Salerno: AI-Powered At-Home Anemia Screening Advances Telehealth Access
-
Sep 24, 2026, 05:38Aya Qattan: When a Normal CBC Does Not Mean Normal Iron Status
-
Sep 24, 2026, 05:11Mastering Warm Autoimmune Hemolytic Anemia Diagnosis and Practice – ASH Education
-
Sep 23, 2026, 16:04Monia Ezzalfani: Advancing Patient-Centered Care in Hemophilia A and B
-
Sep 23, 2026, 15:49Bilge Başak: How Activated PRP Modulates Osteoarthritic Chondrocyte Function
-
Sep 23, 2026, 14:50Mbonjo Bitsie Dora: Strengthening Sickle Cell Care Through Education, Awareness and Innovation
-
Sep 23, 2026, 13:58The New B12 Diagnostic Algorithm: From Serum Cobalamin to Functional Deficiency