Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
HOME > REGULATORY
REGULATORY
- Add Type 1 Diabetes to Opdivo Label: MHLW
November 26, 2015
- Exemption of Clinical Trials in Japanese Subjects Depends on Factors Such as Possibility to Infer Safety: PMDA
November 26, 2015
- Chuikyo Agrees on Setting Range, Not Fixed Threshold, to Judge Cost Effectiveness of Drugs
November 25, 2015
- Don’t Seek Near-Term Profits but Have Long-Term Vision, MHLW Official Tells Drug Makers
November 25, 2015
- MOF Panel Submits Budget Recommendation, Calls for Wrapping Up Talks on Frequency of Drug Price Revisions by Mid-2018
November 25, 2015
- AMED to Allocate 150 Million Yen to Development of In Vitro Diagnostics for Breast and Colorectal Cancer
November 25, 2015
- Generic Prices Should Be Below 50% of Original Drug Prices: Govt Panel Members
November 25, 2015
- MHLW Eyes Using HTA to Re-Price Drugs with Big Sales Outlooks That Have Gone Through 1 or 2 Price Revisions
November 24, 2015
- MHLW OKs Add’l Indications for Lexapro, Other Drugs
November 24, 2015
- Bristol’s MM Drug Elotuzumab Gets Orphan Status
November 24, 2015
- Chuikyo Advisor Submits Guidelines for Cost-Effective Assessments that Would Include Measures Other than QALY
November 24, 2015
- AMED Looks to Bridge “Valley of Death” with Pre-Orphan Designation Scheme
November 20, 2015
- Pharmas Present 9 Requests on Drug Pricing, Tax to LDP Study Group
November 20, 2015
- MHLW Panel Approves Additional Shipment of Kaketsuken’s Venilon, Novact
November 20, 2015
- Viekirax Price, Peak Sales Forecast Called into Question
November 19, 2015
- Chuikyo OKs Viekirax, Other Drugs for NHI Price Listing on Nov. 26
November 19, 2015
- Chuikyo Approves Listing of Temcell and HeartSheet, First Two Regenerative Medicine Products
November 19, 2015
- AbbVie’s Hep C Drug Viekirax Priced at 53,000 Yen Daily vs. Harvoni’s 80,000 Yen
November 18, 2015
- MHLW Cautions against Reference Pricing, Says Impact on Pharmas Would Be Huge
November 18, 2015
- Research-Driven Drug Makers Should Collaborate with Startups, Academia: MHLW Official
November 17, 2015
ページ
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…