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 Panel Backs Lilly’s Ibrance Contender Abemaciclib for Breast Cancer
August 6, 2018
- Daiichi Sankyo's Herceptin Biosimilar Now in Line for September Approval as It Clears MHLW Panel
August 6, 2018
- MHLW Vaccine Panel to Continue Discussion on Pneumococcus in Elderly, Inactivated Polio Vaccine
August 3, 2018
- MHLW Panel Rebuffs Nonprescription Switches of 3 PPIs
August 3, 2018
- MHLW Orders Label Revisions for Otezla, Ceftriaxone
August 3, 2018
- Fusion of Registry Network and MID-NET Will Change Clinical Trial Landscape in Japan: MHLW Official
July 31, 2018
- Inappropriate Drug Promotion at Clinics Involves Encouragement of Off-Label Use in Most Cases: Study
July 31, 2018
- Boehringer’s DPP-4/SGLT2 Combo Clears MHLW Panel
July 30, 2018
- Govt Revises Basic Policy of Asia Health Initiative, with New Focus on Promoting Access to Drugs in Asia
July 27, 2018
- MHLW Panel Wraps Up 1st Round of Debates on PMD Law Amendment, Elaborate Discussions Slated to Start in September
July 26, 2018
- MHLW Shuffles Senior Bureaucrats, Health Insurance Chief Suzuki Tapped for Top Post
July 25, 2018
- AMED Launches Study on Evaluating the Quality and Safety of Nucleic Acid Medicines to Promote Their Development
July 25, 2018
- Discussions Needed for “Biosame” Products: MHLW Official
July 24, 2018
- Lilly’s Breast Cancer Med Abemaciclib Up for MHLW Panel Review on Aug. 3
July 23, 2018
- Lawmakers Question Rationale for PMD Law Amendment as LDP Launches Debate
July 19, 2018
- Scope of Japan-EU GMP Mutual Recognition Agreement for Pharmaceuticals Expanded: MHLW
July 19, 2018
- Boehringer’s DPP-4/SGLT2 Combo Up for MHLW Panel Review on July 27
July 17, 2018
- MHLW to Introduce Guidelines for Sales Reps’ Activities, Calling for the Creation of Supervising Offices
July 17, 2018
- New Medical Infrastructure Law to Pave Way for Database on 50 Million People: Govt Official
July 13, 2018
- MHLW Orders Removal of Pregnancy Contraindications for 3 Immunosuppressants
July 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…