Blog
Expert analysis on Japan's pharmaceutical regulatory landscape.
PMDA Drug Approval Process: A Complete English Guide for 2026
Step-by-step guide to Japan's drug approval process — application types, review timelines, SAKIGAKE designation, and tips for foreign companies.
PMDA vs FDA: Key Differences Every Regulatory Team Should Know
Side-by-side comparison of Japan's PMDA and the US FDA — review timelines, clinical requirements, submission formats, and cross-market approval data.
Japan Drug Registration Requirements: What Foreign Companies Need to Know
MAH requirements, bridging studies, GMP inspections, NHI pricing, and common mistakes — everything for entering the Japanese pharmaceutical market.
How to Access PMDA Review Reports in English: The Definitive Guide
Only ~300 of thousands of PMDA review reports have been translated to English. Here's how to find them and what to do about the rest.
Japan Pharmaceutical Market in 2026: Size, Trends, and Regulatory Outlook
Japan's $84B+ pharmaceutical market — growth drivers, key players, regulatory modernization, pricing reforms, and opportunities for foreign companies.
PMDA eCTD v4.0 Mandate: The Complete Guide for 2026
Japan's PMDA is the first major regulatory authority to mandate eCTD v4.0, effective April 1, 2026. Everything your team needs to know.