REGULATORY

• Study Group Calls for Independent Body to Centrally Manage Whole Genome Data
  January 16, 2026

• Expert Calls for Full Verification of CEA Guidelines and Analytical Frameworks
  January 16, 2026

• Japan Sets New Pricing Rules for Conditionally Approved Regenerative Medicines, Starting with Elevidys
  January 15, 2026

• MHLW Orders Label Revisions for Aspirin, CAR-T Therapies, and Other Drugs
  January 14, 2026

• Japan to Stick with 7 New Drug Approval Rounds a Year
  January 14, 2026

• MHLW to Set Up Expert Panel on Using Disease Registries in Drug Development
  January 13, 2026

• Chuikyo Moves to Allow Special Mixed-Billing for Santen’s Myopia Drug
  January 13, 2026

• Japan Panel to Review AbbVie’s Aquipta, Ipsen’s Sohonos on January 23
  January 13, 2026

• MHLW Pharma Director Says Uniform Drug Price Hike “Not Realistic,” Targeted Support Preferred
  January 9, 2026

• MHLW Issues Guidance on Revised PMD Act Ahead of May Enforcement
  January 6, 2026

• MHLW Sets Up Drug Discovery Support Office Ahead of New Fund Launch
  January 6, 2026

• Ex-JPMA President Ueno Takes on New AMED Advisor Role
  January 6, 2026

• Cabinet OKs FY2026 Tax Reform Package, Creates Strategic Tech R&D Credit
  January 5, 2026

• Chuikyo OKs Medical Materials Reform Outline, Price Hikes Possible for Loss-Making Devices
  January 5, 2026

• MHLW FY2026 Budget Hits Record 35 Trillion Yen, Drug Discovery Support Set at 7.1 Billion Yen
  January 5, 2026

• Gist of FY2026 Drug Pricing Reform Outline
  December 26, 2025

• Japan Puts CEA Expansion on Hold, Sets 6-Month “Technical Discussions”
  December 26, 2025

• Chuikyo OKs FY2026 Drug Pricing Reform Outline, Scraps “Spillovers” but Adds New Follow-Up Rules
  December 26, 2025

• Japan Cabinet OKs Record Social Security Spending in FY2026 Budget, 105 Billion Yen in Drug Price Cuts
  December 26, 2025

• MHLW Names 77 Active Ingredients for OTC-Like Drug Charges
  December 26, 2025

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