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
- Orphan Status Granted to Satralizumab, 2 Other Drugs
September 17, 2019
- Show Us Concrete Proposals for Drug Pricing Reform: Kyokai Kenpo Director to Pharma
September 13, 2019
- Chuikyo Agrees on Need to Look at More Examples to Craft Pricing Models for Cell & Gene Therapies
September 12, 2019
- Both Payer, Doctor Members Want to Expand Comparator PMP Removal Rule, but Mixed on Timing: Chuikyo
September 12, 2019
- Chuikyo Members Open to Post-Launch Premiums for Add’l Indications, but Call for Careful Application
September 12, 2019
- 9 Topics Presented towards 2020 Pricing Reform; Industry Hearing Slated for November-December: Chuikyo
September 12, 2019
- Katsunobu Kato Makes Comeback as Health Minister
September 11, 2019
- MHLW Vows to Redouble Efforts to Prevent Future Information Leaks
September 11, 2019
- RWD Use in Regulatory Submissions Could Start with Rare Diseases: PMDA Chief
September 10, 2019
- MOF Budget Examiner Sounds Alarm on “Protected” Market, Prods Speedy Transformation
September 10, 2019
- MHLW Eyes More Convenient Sakigake Scheme with Legislation, Criteria Won't Change: Official
September 10, 2019
- Evenity Ordered to Warn of CV Event Risks in Revised Label
September 9, 2019
- MHLW to Launch 5th Round of Sakigake Invitations on Oct. 1
September 9, 2019
- MHLW Loathe to Disclose Probe Documents on Clinical Research Bill Leak
September 6, 2019
- In Fight against AMR, Japan Set to Forge Prefectural Networks to Push Proper Antibiotic Use
September 5, 2019
- Senior Bureaucrat Chided for Leaking Draft Clinical Research Bill
September 4, 2019
- Japan, Vietnam Regulators to Hold 1st Joint Symposium Next Month
September 4, 2019
- Japan Drug Production Up 2.8% to 6.9 Trillion Yen in 2018: MHLW
September 2, 2019
- MHLW’s Health Policy Bureau Requests Increased Budget for Core Hospitals, Centers for Pediatric and Rare Diseases
September 2, 2019
- MEXT Requests 103.4 Billion Yen to Fuel Healthcare R&D in FY2020
September 2, 2019
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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…