Articles tagged with “regulatory-affairs-japan”

Japan's Drug Approval Process: A Guide to PMDA & MHLW

Learn about Japan's drug approval process. This guide covers the PMDA & MHLW roles, review timelines, drug lag, and expedited pathways like SAKIGAKE.

45 min read

10/27/2025

japan drug approval process pmda mhlw pharmaceutical regulation drug lag sakigake designation pmd act regulatory affairs japan

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