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 Takes Public Comments on Distribution Management Plan for Shionogi’s ADHD Treatment Vyvanse
December 12, 2018
- Govt’s Draft Reform Timeline Prods MHLW to Discuss Use of “Economic Evaluations” in Reimbursement Decisions in FY2019
December 11, 2018
- Big Improvement in Single-Product, Single-Price Transaction Rate in April-Sept.; Over 90% with Dispensing Pharmacy Chains
December 11, 2018
- Spinraza under PMDA Risk Review for Hydrocephalus
December 10, 2018
- R&D Tax Credit Refit Taking Shape; Open Innovation Scheme Likely to Cover Research Commissioned to Big Firms
December 10, 2018
- Council Holds Off Nonprescription Switches of PPIs Despite Public Support
December 10, 2018
- JPMA Official Renews Call for Use of “Specified Clinical Research” Data in Application Dossiers
December 7, 2018
- Burden on Clinical Research Core Hospitals Should Be Reduced: HSC Panel Chair
December 7, 2018
- National Institute of Public Health to Play Core Role in CEA Public Analysis Process
December 6, 2018
- Chuikyo Agrees on 3 ICER Thresholds for “Tiered” CEA Price Adjustment Model; Industry Hearing Slated by Year-End
December 6, 2018
- Japan Pharma Chief Happy with Direction of Chuikyo Debates on Tax Hike-Linked Price Revision
December 6, 2018
- ViiV’s HIV Drug Juluca to Join NHI Price List on Dec. 12
December 5, 2018
- Survey Suggests 5% Regular Price Cut in 2019, 2% Tax Hike to Offset Reduction
December 5, 2018
- MHLW Panel OKs Amgen Astellas’ Romosozumab, but ADHD Drug Vyvanse Put on Hold
December 4, 2018
- Keytruda’s Tumor-Agnostic Use, Gilead’s Epclusa, Wider Hemlibra Label Now in Line for Approval by Year-End
November 30, 2018
- Govt Deregulation Team Calls for Review of Info Required in Micatrio Reimbursement Claims
November 30, 2018
- LDP Lawmakers Push for Expansion of R&D Tax Credit
November 30, 2018
- AMED Study Group Drafting Japan’s 1st Guidelines for Development of Recombinant Virus Vaccines
November 29, 2018
- MHLW Orders Label Revisions for Mitsubishi Tanabe’s Zione; “Anaphylaxis” to Be Added to Adverse Reactions
November 28, 2018
- Certain Amount of Production Hikes of Measles-Rubella Vaccine in Japan Possible: Health Minister
November 28, 2018
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International regulators are increasingly moving away from comparative efficacy studies (CES) in biosimilar development — long considered a default requirement…
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…