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Mon. Mar 16, 2026

Tue. Mar 17, 2026

Wed. Mar 18, 2026

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Premarket regulations and regulatory assistance offered by the PMDA for new drug development

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.

The 99th Annual Meeting of the Japanese Pharmacological Society

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[2-S-04]Premarket regulations and regulatory assistance offered by the PMDA for new drug development

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