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
- MHLW to Discuss Drug Wholesalers’ License Requirements Related to Their “Operational Systems”
October 23, 2017
- MHLW to Discuss Redefinition of Drug “Seals”, Will Revise List of Examples of Seals Included in 1961 Notification
October 23, 2017
- Japan Introduction of GDP Likely to Begin with Guideline that Calls on Companies to Make “Good Faith Effort”: MHLW Study Group
October 23, 2017
- MHLW Advisory Panel to Discuss Pediatric Dosages for Nexium on Nov. 2
October 20, 2017
- Restrictions on Continuous Psychotropic Use Up for Chuikyo Discussions
October 19, 2017
- Price Maintenance Premium, Z2 Reduction Rates under Attack by CEFP Working Group
October 19, 2017
- Chuikyo Discussing Measures to Promote Proper Use of Clozaril for Patients with Treatment-Resistant Schizophrenia
October 19, 2017
- National Database Initiative for Regenerative Medicine Goes Live; Use for Review, Development Eyed
October 18, 2017
- Label Revisions Ordered for 5 APIs, Hitting Slew of Amoxicillin/Chlorhexidine Products
October 18, 2017
- Post-Transplant Patients Added to Careful Use List for Keytruda Label/Guidelines
October 18, 2017
- MHLW to Issue Notification on Revised Format for Package Inserts of Vaccines in Early December
October 18, 2017
- Cabinet Secretariat to Discuss Details of Research on Genome Editing to Be Supported by AMED
October 16, 2017
- MHLW to Purchase Enough Avigan for 44,000 More People, Agreement Expected Nov. 1
October 13, 2017
- Pricing Predictability Could Crumble via Japanese CEA Introduction, Tada Frets at Chuikyo
October 12, 2017
- Premium Rate Threshold Could Preclude CEA-Based Price Raise for Inapplicable Products: Chuikyo Doctor Rep
October 12, 2017
- FPMAJ Chief Trades Barbs with Chuikyo Payer Rep, Says Western-Style HTA Doesn’t Fit Japan’s Unique Market Mechanism
October 12, 2017
- Claims to ADR Victims Relief System Up 277 in FY2016: MHLW
October 12, 2017
- Any CEA-Based Price Adjustment Must Be Limited to Premium Rates: 3 Pharma Groups
October 11, 2017
- MHLW to Issue Basic Guide to PMS for Conditional Early Approval: Drug Review Chief
October 11, 2017
- Japan Needs “Quick and Low-Cost” R&D Setup: Top MD Bureaucrat
October 10, 2017
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