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
- MHLW Draft Budget Earmarks 8.99 Billion Yen for Drug-Related Projects
December 26, 2018
- 44 Million Yen Allotted to Fuel Biologics Development: Health Policy Bureau’s FY2019 Budget
December 26, 2018
- Japan OKs FY2019 Budget, Record 34.6 Trillion Yen Earmarked for Social Security
December 25, 2018
- MHLW OKs Add’l Indications for Keytruda, Tecentriq, Hemlibra, and More
December 25, 2018
- After Settling on October 2019 Re-Pricing, When Will Govt Reveal New Drug Prices?
December 21, 2018
- Clarify Definition of Ads to Not Hamper Info Delivery to Patients: PhRMA Tells Govt
December 21, 2018
- CEFP Finalizes Govt Reform Timeline Urging FY2019 Debate on “Economic Evaluations” for Reimbursement Decisions
December 21, 2018
- Approvals for Epclusa, Keytruda’s MSI-H Indication and More Could Be Delayed into 2019
December 21, 2018
- Chuikyo Snubs Industry’s Call to Exclude Listed Products from CEA Scope
December 20, 2018
- PhRMA, EFPIA Pitch Enhanced Appraisal Model for Japan HTA Plan; Chuikyo Reps Acknowledge ICER Limitations
December 20, 2018
- Govt to Pare Drug Prices by 2.4% in October 2019 Ad-Hoc Re-Pricing
December 19, 2018
- MHLW Revises Conditions of Approval for Alecensa Based on Findings from Post-Marketing Survey
December 19, 2018
- MHLW Compiles Proposal for PMD Law Amendment, Eyes Diet Submission of Related Bill Next Year
December 18, 2018
- Ministers Agree on Ad-Hoc Drug Re-Pricing in October 2019, 29 Billion Yen Saving in State Coffers
December 18, 2018
- MHLW Committee on Medical Devices Recommends Approval of 2 Cancer Gene Panel Tests
December 17, 2018
- MHLW Panel Approves Plan to Amend Blood Law
December 17, 2018
- Govt to Tap R&D Tax Credit System to Push Research on Pediatric Use, Superbug Fight
December 13, 2018
- Authorized Generics for Iressa, Urief to Join NHI Price List; Nesp Biosame Skips Listing
December 13, 2018
- Chuikyo Adopts Outline of 2019 Drug Price Revision for Sales Tax Hike
December 13, 2018
- MHLW to Offer Free Rubella Shots to Men Aged 39-56
December 12, 2018
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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…