2025.03.11
2024 New Drug Approvals in Japan: Company Rankings and Trends
Overview of New Drug ApprovalsAccording to the report (2024年 国内新薬承認取得数ランキング…最多は11承認のアストラゼネカ、新規有効成分はファイザーがトップ | […]
2025.02.27
Astellas Seeks Conditional Approval in Japan for Geographic Atrophy Treatment Without Japanese Patient Data
Introduction to Astellas’ Pioneering Regulatory Submission According to the news (News | Astellas Pharma Inc.) […]
2025.02.06
2024 Top-Selling Pharmaceuticals in Japan
Overview of Japan’s Pharmaceutical Market in 2024 According to the news (【2024年国内医薬品売上高トップ10】キイトルー […]
2025.01.21
Japan’s Upcoming Amendments to the Pharmaceutical and Medical Device Act
Japanese Pharmaceutical and Medical Device Act revisions aim to establish a pharmaceutical industry that ensures stable and reliable access to medicines for the public.
2024.12.16
PMDA Washington Office Begins Operations: Building Bridges for U.S. Startups to Japan
PMDA Washington Office Begins Operations: Building Bridges for U.S. Startups to Japan Introduction Accor […]
2024.12.02
Japan’s New Approach to Tackling Drug Loss
Japan’s New Approach to Tackling Drug Loss Introduction According to the news (ドラッグ・ロス、まず78品目を解決 国主導で、新たに発生した […]
2024.11.15
Japan’s New Guidelines for Orphan Drug Approvals Without Japanese Clinical Trial Data
Japan’s New Guidelines for Orphan Drug Approvals Without Japanese Clinical Trial Data Introduction to New Appr […]
2024.10.25
Japan’s Latest Revisions to the Pharmaceutical and Medical Device Act
Japan’s Latest Revisions to the Pharmaceutical and Medical Device Act Introduction to Regulatory Revisions&nbs […]
2024.10.08
Key Regulatory Review Systems for Pharmaceuticals in Japan
Key Regulatory Review Systems for Pharmaceuticals in Japan Overview: Japan’s Ministry of Health, Labour, and W […]
2024.09.25
MHLW FY2025 Budget Proposal for the Establishment of Infrastructure to Implement the FIH (First-In-Human) Trial for Global Development
MHLW FY2025 Budget Proposal for the Establishment of Infrastructure to Implement the FIH (First-In-Human) Tria […]