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[V4-S4] Are the Drugs Appropriately Reaching to the Pediatrics in Needs? - Current Development Status and Future Steps of Pediatric Drugs in Japan -
Session Chair(s)
Natsuko Hamada
Head of Regulatory Affairs, Swedish Orphan Biovitrum Japan, Japan
While drug-lag is being solved with the advance in Global drug development, currently, development of pediatric drugs in Japan is lagging behind. The development of pediatric drugs is ongoing in EMA under PIP (Pediatric Investigation Plan), and in FDA under PSP (Pediatric Study Plan). Now that Global drug development including Japan is becoming a main stream, a discussion has started for Japan to join in Global drug development also for pediatric drugs. In US and Europe, over 10 years have passed since the development of pediatric drugs (PSP, PIP) were promoted by the national governments. With Addendum to ICH E11 is currently at Step3, upon receiving future prospects in Japan from MHLW and PMDA, this session will hold a progressive discussion on promoting the development of pediatric drugs in Japan from government-industry-academia stance, respectively.
Speaker(s)
Masakatsu Imoto
, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
New Approach for Pediatric Medicines in Japan
Masao Nakagawa, MD
, Japan Pediatric Society, Japan
The Role of Japan Pediatric Society for Promotion of Pediatric Drug Development
Masakazu Hirata, MD, PHD
Clinical Reviewer, Division of RS Consultation, Kansai Branch, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Pediatric Drug Development in Japan and International Regulatory Collaboration
Katsuaki Sato
, GlaxoSmithKline K.K., Japan