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
- 2 mRNA Jabs Ordered to Add Myocarditis to ADR List: Label Revision
December 6, 2021
- Panel OKs Outline of Emergency Approval System Based on “Presumed” Efficacy
December 6, 2021
- MHLW Issues Revised Drug Distribution Guidelines; Effective January 1
December 6, 2021
- MOF Panel’s Budget Proposal Pushes Macroeconomic Indexing, No Adjustment Rate
December 6, 2021
- Pharma Industry Wants Grace Period of at Least 5 Years for Spillover Exclusion Rule
December 6, 2021
- Japan Generic Share at 79% in September 2021: Drug Price Survey
December 6, 2021
- Average NHI-Market Price Gap of Listed Drugs at 7.6%: MHLW
December 3, 2021
- Amgen’s KRAS Inhibitor, MSD’s Cough Drug Sail through PAFSC, January Approval Likely
December 3, 2021
- 70% of Pharmacies Procured Alternative Products due to Generic Scandals in FY2020: Chuikyo Survey
December 3, 2021
- Chuikyo Defers Coverage for SaMD for Breast Cancer Recurrence Risk Assessment; Software Remains Incomplete
December 3, 2021
- MHLW Eyes Emergency Approval System Based on “Presumed” Efficacy
December 2, 2021
- Chuikyo OKs 2022 Reform Outline for Cost-Effectiveness Assessment System
December 2, 2021
- Chuikyo Reps Acknowledge Need for Adjustment Rate: 2022 Price Revision
December 2, 2021
- Chuikyo Members Call for Restrictions in Re-Pricing Exclusions from Spillover Rule
December 2, 2021
- ICH Adopts E8, M8 Guidelines; 3 Topics Reach Step 2
December 2, 2021
- MHLW to Conduct Supply Chain Survey for Key Drugs
December 1, 2021
- LDP Pharma Study Group Urges 2% Adjustment Rate Plus Certain Range for 2022 Price Revision
December 1, 2021
- Japan Confirms 1st Case of Omicron Variant: MHLW
December 1, 2021
- MHLW Plans March Listing for “Off-Year” 2023
November 30, 2021
- Alzheimer’s Drugs in Mind, MHLW to Float New Rule for Potential Super Big Sellers
November 30, 2021
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Chugai Pharmaceutical’s Duchenne muscular dystrophy (DMD) gene therapy Elevidys has finally reached the Japanese market after months of safety reviews…
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…