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
- EU OKs Export of 1st Batch of Pfizer’s Coronavirus Vaccines: Minister
February 10, 2021
- Kobayashi Kako Slapped with Record 116-Day Business Suspension
February 9, 2021
- Pfizer’s COVID-19 Shot Up for PAFSC Review Feb. 12, Kono Expects Govt to Secure Enough Doses for 1st-in-Line HCPs
February 9, 2021
- Regulators to Issue Biz Suspension Order to Kobayashi Kako on Feb. 9
February 8, 2021
- MHLW, Saudi Govt Sign Memo on Regulatory Harmonization; Japan-Listed Drugs to Get Priority Review
February 4, 2021
- Drug Pricing Rules to Be Applied to Yescarta: Chuikyo
February 4, 2021
- Celgene’s Liso-Cel Up for PAFSC Review on Feb. 17, 3rd CAR-T Therapy in Japan
February 4, 2021
- New EU Export Regulations Affecting Japan’s Vaccine Supply Schedule: Kono
February 3, 2021
- Japan Moves Up Vaccine Rollout Target to Mid-February, PAFSC Review on Feb. 12?
February 3, 2021
- Japan Govt to Nearly Double Caps for COVID-19 Municipal Grants: Kono
February 2, 2021
- Japan Weighs Workplace Vaccination for COVID-19
February 2, 2021
- MHLW Issues List of Wholesalers Responsible for COVID-19 Vaccine Distribution in Each Region
February 2, 2021
- PMDA Reviewing Safety Risks for NSAIDs, and More Products
February 1, 2021
- Govt Giving Advice to Fujifilm after Shelving Decision on Avigan
February 1, 2021
- PAFSC OKs Seikagaku’s Osteoarthritis Med for Use Excluding Ankle Joints, Bayer’s Larotrectinib Too
February 1, 2021
- Japan Enacts 3rd Extra Budget, 4.4 Trillion Yen to Stem Spread of COVID-19
January 29, 2021
- MHLW Wants to Encourage Non-Monitoring Facilities to Report Inappropriate Drug Promotion
January 29, 2021
- Fujimoto’s Thaled Now in Line for Approval for POEMS Syndrome
January 28, 2021
- MHLW Official Urges Pref. Govts to Implement Thorough Inspection, Guidance for Drug Makers after Kobayashi Kako Fiasco
January 28, 2021
- LDP COVID-19 Vaccine Project Team to Compile Proposal before Rollout
January 27, 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…