Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
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REGULATORY
- Jardiance’s CKD Indication in Line for Japan Approval with Key Panel Nod
January 29, 2024
- Break-Up of LDP Factions Won’t Have Major Impact on Pharma Policy, but Could Make Lobbying Tougher
January 26, 2024
- MHLW Holds 1st Meeting to Consider Structure of Japan CDC
January 26, 2024
- MHLW No Longer Requires Japanese Comparability Data for Certain Biosimilars: Q&A Update
January 26, 2024
- Cases of Xocova Use in Pregnant Women Now Total 34: MHLW
January 24, 2024
- As Japan Sees Uptick in COVID Cases, Minister Says to Watch Situations
January 24, 2024
- PMDA Sets 6-Month Target for All SaMD Products under Priority Review
January 23, 2024
- Label Expansion for Opdivo, Olumiant, Dupixent Up for PAFSC Review on Feb. 5
January 23, 2024
- MHLW Urges Prioritized Delivery of Drugs under Shipment Control to Ishikawa
January 22, 2024
- Requests Raised on LLP Coverage Rule, Supply Issue: Chuikyo Public Hearing
January 22, 2024
- PMDA Reviewing Safety Risks for 12 Drugs including Kinase Inhibitors
January 22, 2024
- Japan Approves Pfizer’s RSV Jab, Ultragenyx’s Evkeeza, and More
January 19, 2024
- Market Expansion Re-Pricing to Hit 23 Meds in April, Opdivo Faces Yet Another Cut in Spillover
January 18, 2024
- Updated Rules OK’ed for FY2024 Reform, 5-10% Rate Set for New Premium to Counter Lag/Loss
January 18, 2024
- 9 APIs to Earn Increased Premiums in FY2024 Price Revision; Jakavi Gets Multiple Premiums
January 18, 2024
- MHLW Publishes Report on Drug Marketing System towards PMD Law Amendment
January 17, 2024
- MHLW Issues Notification to Clarify Orphan Designation Criteria
January 17, 2024
- FY2024 Reform Will Bolster Rewards for Innovation to Eradicate Drug Lag/Loss: LDP Policy Bigwig
January 16, 2024
- Legal Changes Needed to Push Use of Pseudonymized Data in Drug R&D: MHLW Working Group
January 16, 2024
- MHLW’s Planned Bill Would Exclude Certain Programs from “Specified Clinical Trials”
January 16, 2024
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