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
- Over 30% of Drug Makers Spot Inappropriate Promotions after Guidelines Enforcement
June 16, 2021
- Report Systems for Improper Drug Promotion Little-Known among Pharmacists: MHLW Study
June 16, 2021
- LDP Group Urges Stable Generic Supplies, Submits Proposal to MOF
June 16, 2021
- Label Revisions Ordered for New Safety Risks of Keytruda, Taltz
June 16, 2021
- Honebuto Text to Add Line for “Transparency and Predictability” of Drug Pricing System
June 16, 2021
- MHLW Panel Recommends Lifting Ban on Cannabis-Derived Drugs, Eyes Legal Amendment Next Spring
June 15, 2021
- ICH Adopts Topic on Use of Real-World Data
June 15, 2021
- LDP Flags 80% Generic Target for All Prefectures: Honebuto Debate
June 11, 2021
- No Major Concerns over Safety of Moderna, Pfizer COVID-19 Vaccines: MHLW
June 11, 2021
- Govt Unveils Draft Honebuto Paper for 2021, Cabinet OK Expected after Party Tweaks
June 10, 2021
- Japan PM Vows to Vaccinate All People by October-November
June 10, 2021
- LDP Panel Urges 500 Billion Yen Support over 10 Years for Japan-Made Jabs
June 9, 2021
- Japan Aims for 80% Generic Share in All Prefectures by FY2023-End: Honebuto Draft
June 9, 2021
- 33 New Products Including Celecoxib Added to 18th Edition of Japanese Pharmacopoeia
June 8, 2021
- G7 Health Ministers Adopt Declaration Aimed at Greater Cooperation to Expedite Drug, Vaccine Development
June 8, 2021
- Label Revision Ordered for Clozaril to Increase Blood Testing Interval, Relaxed Re-Administration Criteria
June 4, 2021
- MHLW Mulls Sakigake System for SaMD with Medical Device as a Model: Official
June 3, 2021
- LDP Group on Generics Calls for Sustainable Supply Scheme: Proposal
June 3, 2021
- Japan to Establish Ecosystem to Deliver Innovative Drugs: Draft Growth Strategy
June 3, 2021
- Deregulation Panel Prods Govt to Fuel SaMD Development
June 3, 2021
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Chugai Pharmaceutical’s Duchenne muscular dystrophy (DMD) gene therapy Elevidys has finally reached the Japanese market after months of safety reviews…
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…