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.
-
Jun 23, 2026, 23:05Rounak Dubey: ISBT Academy Session on Agentic AI
-
Jun 23, 2026, 22:59Mohammed Maher Babiker: When ‘Low Platelets’ aren’t Really Low
-
Jun 23, 2026, 22:49Giovanni Merlino: Why Does Stress Hyperglycemia Worsen Stroke Outcomes?
-
Jun 23, 2026, 22:41Tareq Abadl: Coombs Test – The Key to Detecting Immune-Mediated Hemolysis
-
Jun 23, 2026, 22:32How WFH Impacted the Bleeding Disorders Community in 2025
-
Jun 23, 2026, 22:03Erin VanDyke: A Journey Through VTE Leadership and Healthcare Transformation
-
Jun 23, 2026, 21:19Ahmed Koriesh: Join Us for Future of Stroke Care 2026
-
Jun 23, 2026, 20:30Aladdin Mohammad: Baseline IgG as a Key Predictor of Hypogammaglobulinaemia in AAV
-
Jun 23, 2026, 19:20Simos Kokkovos: 1st Ever Mobile Stroke Unit in Greece is on its way to Metropolitan Hospital