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
- Pfizer’s Sakigake-Designated Vyndaqel, Shionogi’s Vyvanse Up for MHLW Panel Review on Feb. 21
February 8, 2019
- 4 Public Comments Received for Ad-Hoc Re-Pricing in October
February 7, 2019
- MHLW Panel to Discuss Orphan Status for Takeda’s Stem Cell Therapy on Feb. 20
February 7, 2019
- Importance of Non-ICER Factors in Cost-Effectiveness Assessment Starting to Resonate with Chuikyo Reps
February 7, 2019
- Tough CEA Rules for Cost-Based Method Products Targeting Imports: EFPIA Japan Vice Chair
February 7, 2019
- Japan, US, European Trade Groups Give Opinions on Govt’s CEA Proposal: Chuikyo
February 7, 2019
- Kymriah Up for MHLW Panel Review on Feb. 20 as Japan’s 1st CAR-T Therapy
February 6, 2019
- MHLW Informs of Outlines for New Package Insert Format to Be Introduced in April
February 6, 2019
- Key MHLW Panel Backs Iron Replacement Therapy Ferinject, No Vyvanse Review
February 1, 2019
- Faulty Wage Data Might Have Affected Drug Pricing as Labor Stats Used for Cost-Based Method
January 31, 2019
- Janssen’s Erleada Clears MHLW Panel Review, Now in Line for March Approval
January 31, 2019
- Pharmacies Fret Inventory Value Dip, Negative Margins due to Tax Hike-Linked Re-Pricing: Chuikyo Public Hearing
January 31, 2019
- MHLW Calls for Thorough Check on Drugs after Cyanide Blackmail
January 30, 2019
- PMDA Eyeing Staffer Increase of Around 150 over Next 5 Years, Official Suggests
January 29, 2019
- MSD to Tap MID-NET Database for Erelsa/Grazyna in 3rd Private Sector Use
January 29, 2019
- MHLW Revises Notifications on Electronic Data Submission as End of Grace Period Approaches
January 28, 2019
- Resistant Virus Found in Kids Administered Xofluza: NIID
January 28, 2019
- NITE, Genome Pharmaceuticals Institute Jointly Explore Rare Actinomycetes for MRSA
January 28, 2019
- “Detailed Discussions” Necessary for Use of Real World Data: HSC Panel
January 25, 2019
- MHLW Unveils Outline of Cost-Effective Assessment Scheme: Chuikyo
January 24, 2019
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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…