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Shunsuke Iwano: PMDA Introduces Greater Flexibility for Pediatric Factor VIII and IX Development in Japan
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.”

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bleeding disorders Factor IX Factor VIII Health Hematology Hemophilia Hemostasis Hemostasis News Hemostasis Today Japan Medicine pediatric rare disease PMDA Shunsuke Iwano
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