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 to Map Out Additional Step against Rubella Outbreak by Year-End
October 25, 2018
- MHLW Warns against Advertising Claims Suggesting that OTC Cinnamon Bark Products Can Cure Diabetes
October 25, 2018
- AMED Selects 10 More Projects for CiCLE Grant Program, 4 for New Program to Support Startups
October 24, 2018
- MHLW Orders Label Revisions for Lamotrigine to Include Hemophagocytic Syndrome in ADR List
October 24, 2018
- 70% of Wholesalers Have Received Returns of “Opened and Resealed” Drugs: MHLW Survey
October 22, 2018
- MHLW Proposes New Approval Framework Incorporating Conditional OK, Sakigake Scheme
October 19, 2018
- Council Approves MHLW’s Plan to Deal with Difficult-to-Develop Drugs and Indications
October 19, 2018
- PMDA to Focus on Proper Use of Sakigake and Conditional Approval Systems in Its 4th Midterm Plan
October 19, 2018
- Council OKs Public Knowledge-Based Applications for Add’l Pediatric Indications for Blopress
October 19, 2018
- Chuikyo Wary on CEA Use for Reimbursement Decisions as MHLW Sorts Out Discussion Points towards Full Rollout
October 18, 2018
- 3 Pharma Groups Warn against Drug Price Cut in April 2019: Chuikyo
October 18, 2018
- MHLW Lifts Contraindications for Combined Statin-Fibrate Use in Renal-Impaired Patients
October 17, 2018
- ADR Victim Relief Claims Fall below 1,500 in FY2017: MHLW
October 17, 2018
- As Abe Vows to Deliver on Tax Hike Plan, 3 Pharma Groups to Push for October 2019 Price Revision
October 16, 2018
- MEXT Kicks Off “Open Innovation Organization” Initiative, 3 Universities to Push Drug Discovery
October 15, 2018
- Nobel Laurate Honjo Prods Minister on Industry Consolidation
October 12, 2018
- MHLW Panelists Frown on Use of Economic Evaluations for Reimbursement Decisions
October 11, 2018
- MOF Reiterates Drug Cost Optimization, but Makes No Fresh Proposal: Fiscal System Council
October 10, 2018
- Govt Panel Kicks Off Discussions on “Social Security for All Generations”
October 9, 2018
- Social Security Cost Rise in FY2019 Should Be Held Under 500 Billion Yen: CEFP Members
October 9, 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…