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
- PMDA, FDA Team Up to Help Developing Countries to Facilitate Pediatric Drug Development
May 24, 2018
- Revisit Automatic Coverage for New Drugs, Discuss Mandatory CEA: MOF Panel Proposal
May 24, 2018
- No Specific Social Security Cost Target Discussed at CEFP, All Eyes on How to Handle FY2019-FY2021 Elderly Trough
May 22, 2018
- MHLW Presents Schedule for Discussions on Inclusion of 6 Vaccines in Public Vaccination Programs
May 21, 2018
- MHLW-MOF Negotiations Heating Up over Curtailment of Social Security Costs
May 18, 2018
- MHLW Finds 67 Suspected Violations in Sales Reps’ Advertising Activities; Cites Need for Official Reporting System
May 18, 2018
- Working Group Discussions Underway to Address Technical Issues for CEA before Confirmatory Analyses for 7 Products
May 18, 2018
- Warning against Use in Teenagers Should Be Removed from Tamiflu’s Package Insert: MHLW Panel
May 18, 2018
- Chuikyo Rep Frowns on Low Manufacturing Cost Disclosure, Says New Rule Might Need Revisiting
May 17, 2018
- Chuikyo Reps Chide Delay in Parmodia Listing
May 17, 2018
- Pricing OK’ed for Hemlibra, Parmodia; Prevymis 1st in 3 Years to Get At-Launch Premium for Innovation
May 17, 2018
- Japan Dodges “Priority Watch List,” but US Global IP Report Still Cites Concerns on Its Drug Pricing
May 16, 2018
- MHLW Approves Once-Daily Form of MSD’s HIV Drug Isentress
May 15, 2018
- Generic Industry to Ponder New Target Indicator for Post-80% Era
May 14, 2018
- Industry Asked for Legislation for Conditional Early Approval and Sakigake Designation Scheme: MHLW Panel
May 11, 2018
- Chugai’s Anticancer Agent Obinutuzumab Up for MHLW Panel Review on May 23
May 11, 2018
- Japanese Regulators Ink Confidential Arrangements with Danish Counterpart
May 8, 2018
- MHLW Panel Backs Xeljanz for Ulcerative Colitis
May 1, 2018
- MHLW Proposes Discussing Proper Use of High-Cost Biologics in Preparation for Revision of RA Measures
April 27, 2018
- Imfinzi Sails through MHLW Panel, Now in Line for Stage III NSCLC Nod
April 26, 2018
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Japan’s FY2026 drug pricing reform will, for the first time, apply the “G1” price cut rule for long-listed original biologics…
I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…
The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…