Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
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- Honebuto Draft Equivocal on Off-Year Price Cuts, but Focuses on FY2025 Revision
June 12, 2024
- Label Revisions Ordered for Brimonidine, Finerenone, and More
June 12, 2024
- MHLW to Issue Nitrosamine Risk Communication Guidance by June-End; Draft Now Ready
June 11, 2024
- Govt’s New Capitalism Council Proposes Extending Scope of Mixed-Billing Scheme
June 11, 2024
- Japan Enacts Bill to Amend Regenerative Medicine Safety Act, Clinical Trial Act
June 11, 2024
- Make Onsite GMP Inspections Mandatory for Patented Meds and New Generics: MHLW Proposal
June 10, 2024
- MHLW Proposes Creating Legal Provision on RWD-Only Drug Submissions
June 10, 2024
- Japan Eyes Withdrawal Rule for Conditional Approval, More Flexible Nods
June 10, 2024
- LDP Policy Board Endorses Fiscal Consolidation HQ’s Proposal to Extend CEAs
June 10, 2024
- Japan Grants Orphan Tag to Cannabidiol, 6 More APIs
June 10, 2024
- Health-Savvy Lawmakers Urge Revamp of Off-Year Revisions: LDP Policy Panel
June 7, 2024
- Abolish Off-Year Revisions, No to Broader CEA Use: Eto Group to Ministers
June 7, 2024
- LDP League on Medical Patches Urges Clarification of “Medical Necessity” as New Coverage Rule Looms
June 7, 2024
- Japan Eases Rule on Regulatory Submissions for Combination Therapies
June 6, 2024
- Japan Health Ministry Panel Gives Blessing to Novartis’ PNH Drug Iptacopan and More
June 4, 2024
- Make Single IRB Mandatory in Multi-Center Trials That Use Competitive Funds: Deregulation Panel
June 4, 2024
- Finance Minister Acknowledges Wholesalers’ Plight with Frequent Drug Price Revisions
May 31, 2024
- Nitrosamine Guideline to Be Proposed as New Topic for ICH at Fukuoka Confab
May 31, 2024
- Expand Mixed-Billing Scheme to Cover Gene Panel Test: LDP Committee Proposal
May 31, 2024
- Japan Selects JN.1 for COVID-19 Vaccine Formula in 2024-2025 Season
May 30, 2024
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Japan’s pharmaceutical policy appears to be entering a new phase. The government’s newly approved honebuto policy and growth strategy both…
A few weeks ago, I had coffee with a very talented executive. Let’s call him Kenji. He has a great job, a big salary, and a solid team. But he was unhappy. He felt bored and wanted a new challenge.…
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…