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
- Pfizer Skips Listing of Herceptin Biosimilar, Daiichi Sankyo Goes Ahead
November 27, 2018
- MHLW Proposes Introduction of Administrative Fines for Improperly Earned Revenues
November 27, 2018
- MHLW Panel Recommends Conditional Approval for Nipro’s Stem Cell Product for Spinal Cord Injury
November 26, 2018
- MHLW Eyes Drastic Change to Cost Effective Analysis Flow, Enhanced Discussions Upfront
November 22, 2018
- MHLW Proposes Quarterly Product Selections, Price Tweaks for CEA Scheme: Chuikyo
November 22, 2018
- MOF Panel Urges Govt to Use Economic Evaluations for Reimbursement Decisions: FY2019 Budget Recommendation
November 21, 2018
- Amgen Astellas’s Osteoporosis Med Romosozumab Up for MHLW Panel Review on Dec. 3
November 20, 2018
- Keytruda’s MSI-H Cancer Use Up for MHLW Panel Review Nov. 29; Wider Hemlibra Indication, 1st Line Tecentriq Also on Agenda
November 16, 2018
- Chuikyo Agrees on October 2019 Drug Price Revision for Tax Hike, but Final Call Is Up to Govt
November 15, 2018
- MHLW Revises Imfinzi’s Optimal Use Guidelines for NSCLC, Calling for PD-L1 Expression Test
November 15, 2018
- Novo’s Ozempic Skips Listing for 3rd Time 8 Months after Approval
November 14, 2018
- Chuikyo OKs Listing of Astellas’ AML Med, Lilly’s Verzenio and More on Nov. 20
November 14, 2018
- Maviret Faces 25% Price Slash in Quarterly Review
November 14, 2018
- Despite Being 4th in ALK Class, Lorbrena Qualifies for PMP as It Gets 5% Pricing Premium
November 14, 2018
- New Health Minister Stresses Need for Drug Discovery Support at His 1st Confab with Industry
November 13, 2018
- Novartis’ SMA Gene Therapy Filed in Japan on Nov. 1 after US, EU; What Will Happen to Sakigake Status?
November 13, 2018
- MHLW Panel OKs Otsuka’s Alcohol Dependency Drug
November 12, 2018
- Panel Approves Health Ministry’s Proposal to Provide Package Insert Information in Electronic Form
November 12, 2018
- ViiV’s HIV Med Juluca Clears MHLW Panel for Quick Approval
November 12, 2018
- E19, M10 Guidelines Expected to Reach Step 2 at Upcoming ICH Meeting in US
November 9, 2018
ページ
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…