Articles tagged with “orphan-drug-designation”

Japan's PMDA Drug Approval: Standard & Expedited Pathways

Learn about Japan's PMDA regulatory pathways for drug approval under the PMD Act, including 2025 amendments. Covers standard and expedited options like Sakigake, Orphan Drug, and Conditional Approval

45 min read

10/15/2025

pmda mhlw japan drug approval regulatory affairs japan pmd act sakigake designation orphan drug designation expedited review