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
- 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
- PMDA Cuts Fees for Pediatric, Orphan Drug Consultations
May 30, 2024
- LDP Lawmakers’ League on Generics Prods Minister to Rethink Off-Year Revisions
May 29, 2024
- Health Minister Acknowledges Changes after 2016 Decision on Off-Year Revisions
May 28, 2024
ページ
Japan’s pharmaceutical industry is undergoing a structural shift in its workforce, with the role of sales reps shrinking while production…
In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…
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…