Articles tagged with “japan-drug-approval-process”

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

Learn about Japan's drug approval process, updated for 2026. This guide covers PMDA & MHLW roles, review timelines, drug lag, the 2025 PMD Act amendments, eCTD v4.0 mandate, and expedited pathways like SAKIGAKE.

50 min read

10/27/2025

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