2025.10.17
Japan’s Early Consideration on Handling of Japanese Data for Biosimilar Comparability
Introduction to Regulatory Perspective According to the PMDA’s provisional translation released on September 1 […]
2025.09.30
Key Takeaways from the PMDA Symposium on Japanese Phase I Trials Before MRCT Participation
Introduction On August 4, 2025, the Pharmaceuticals and Medical Devices Agency (PMDA) hosted a public symposiu […]
2025.09.17
PMDA Symposium 2025: Key Takeaways for Pediatric Drug Development
IntroductionOn August 27, 2025, the PMDA hosted a symposium titled “Toward Enhanced Pediatric Pharmacotherapy […]
2025.08.26
Expediting Drug Development in Japan: Key PMDA Initiatives
IntroductionPMDA has reduced median new drug review times from over 600 days in 2005 to 333 days in 2023, matc […]
2025.08.05
Otsuka Holdings Accelerates Mid- to Long-Term Strategy in Autoimmune Diseases with 8 Development Programs
Introduction to Strategic Focus on Autoimmune Diseases According to a news article (大塚HD・井上社長兼CEO 自己免疫領域に８つの開発 […]
2025.07.22
Japan’s CAR‑T Cell Therapy Market to Nearly Double by 2030
Introduction to Market Forecast According to a news article (CAR-T細胞療法市場 30年に390億円、24年から２倍近く拡大 富士経済 | ニュース | ミ […]
2025.07.10
Chugai Files for Tumor-Agnostic Indication of Alecensa in ALK Fusion-Positive Solid Tumors
Introduction to Alecensa Indication Expansion According to a news article (中外製薬 アレセンサで小児含むALK陽性固形がんの適応拡大 […]
2025.06.25
JPMA Responds to the 2025 Honebuto Policy: Emphasizing Reform of Cost-Effectiveness Evaluation and Pricing Framework
Introduction to Japan’s 2025 Honebuto Policy According to a news article (製薬協 費用対効果評価「現行の枠組みにとらわれない新たな制度 […]
2025.06.10
Japan’s 2024 Pharmaceutical Market Overview — Record High for the Second Consecutive Year
Introduction to the 2024 Pharmaceutical Market According to the article (24年度国内医療用薬市場 ２年連続で11兆円台、会計年度でも最高 […]
2025.05.29
Key Amendments to the PMD Act — Strengthening Conditional Approval and Post-Market Safety
Introduction to Legislative ProgressAccording to news (薬機法等改正法案 参院厚労委で賛成多数で可決 15項目の附帯決議採択 14日にも成立へ | ニュース | ミク […]