Session Details
[2-S]Basic research, clinical research, and regulatory affairs to deliver novel natural product pharmaceuticals originating in Japan to the world
Tue. Mar 17, 2026 8:30 AM - 10:00 AM JST
Tue. Mar 17, 2026 11:30 PM - 1:00 AM UTC
Tue. Mar 17, 2026 11:30 PM - 1:00 AM UTC
Room 2(A200)
Chair:Chihiro Tohda(Institute of Natural Medicine, University of Toyama), Sumiko Hyuga(Kitasato University)
Natural product pharmaceuticals or botanical medicines refer to drugs containing multiple compounds, namely Kampo formulas and single crude drug medicines. While 148 Kampo formulas for prescription medicine were approved in 1987, no new formulas have been approved since then, nor have any additional indications been achieved. While the establishment of guidance for single crude drug extracts as a pathway to approval as over-the-counter drugs represents significant progress, approval as prescription medicines remains challenging. This symposium will discuss why this has not led to the approval of new drugs, despite recognized efficacy and safety, and what is needed to overcome this obstacle.
[2-S-01]Significance and potential of novel natural medicine development and drug repositioning
*Sumiko Hyuga1 (1. Kitasato University)
[2-S-02]Regulatory Science of Natural Product Pharmaceuticals
*MICHIHO ITO1 (1. National Institute of Health Sciences)
[2-S-03]Research aiming for the social Implementation of botanical medicines: Challenges and issues
*Chihiro Tohda1 (1. Institute of Natural Medicine, University of Toyama)
[2-S-04]Premarket regulations and regulatory assistance offered by the PMDA for new drug development
*Hiroshi Yaginuma1 (1. Pharmaceuticals and Medical Devices Agency)