REGULATORY

• Industry Urges “Objective Review First” for CEA Reform; Payers Push for Expansion
  August 7, 2025

• Welireg, Airwin, Talvey and More Set for NHI Listing; Premiums Wiped Out by “Zero” Rule
  August 7, 2025

• DPO Floats Premium Expansion, Relaxed Criteria towards FY2026 Reform
  August 7, 2025

• Chuikyo Rules Out Long-Term Care Costs in Leqembi CEA, Confirms Price Cut
  August 7, 2025

• Wegovy, Leqvio, Phozevel to Face CEA-Linked Price Cuts in November
  August 7, 2025

• Japan Publishes List of 203 Suspected or Confirmed Nitrosamine Impurities in Medicines
  August 6, 2025

• MHLW Panel OKs RX-to-OTC Switch of Medicon Cough Suppressant for Children
  August 6, 2025

• MHLW Device Review Chief Pledges Evidence-Based Approvals amid Diversifying Technologies
  August 6, 2025

• LDP OKs FY2026 Budget Guidelines, Natural Increase Set at 400 Billion Yen
  August 5, 2025

• PMDA Stresses Science-Based Decisions on Japanese PI Waivers: Symposium
  August 5, 2025

• MHLW Trial Office Head Vows to Make Japan a Preferred Site for Clinical Studies
  August 5, 2025

• MHLW Official Urges Use of New Fund to Drive Reorganization of Generic Sector
  August 4, 2025

• MHLW Issues Guidance on Clinical Trial Design for Radiopharmaceuticals
  August 4, 2025

• Wage-Based Price Premiums on Drugs Not an Option, Says MHLW Insurance Chief
  August 4, 2025

• Japan Panel OKs Taisho’s Insomnia Med, 2 Other NMEs for Approval
  August 1, 2025

• MHLW Selects 20 Organizations to Bolster Drug Discovery Clusters
  August 1, 2025

• MHLW Orders Label Revisions for Semaglutide, Tirzepatide to Include Ileus Risk
  July 31, 2025

• 23 Suspected Promotional Violations Identified for 18 Drugs in FY2024: MHLW
  July 31, 2025

• MHLW Panel to Further Review Positioning of Susmed’s Insomnia App
  July 31, 2025

• MHLW to Link GS1 and YJ Codes in Public Database, Launch Planned for FY2028
  July 30, 2025

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