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
- AMED Ties Up with Korea’s Govt Backed Research Institute
March 31, 2025
- Sakigake Tag Withdrawn for Boehringer, AbbVie APIs
March 31, 2025
- Nitrosamine Detected in Sumitomo’s Arotinolol, but No Recall Planned
March 28, 2025
- Choseido’s Kawauchi Plant Suspended for 1 Month on GMP Violation
March 28, 2025
- Japan Approves J&J’s Lazcluze, Genmab’s Tivdak, and More
March 28, 2025
- Japan Won’t Ban Red No. 3 for Now but Asks Industry for Self-Inspections
March 27, 2025
- It’s Time to Review Conditional Approval System for Regenerative Medicines: MHLW Official
March 27, 2025
- PMDA Stepping Up Efforts to Woo Overseas Startups to Japan
March 27, 2025
- MHLW Presents Expected Roles of Clinical Research Hospitals towards Criteria Review
March 26, 2025
- Raise Deduction Cap for Self-Medication Tax Break: OTC Industry Chief
March 26, 2025
- NCC President Nakagama to Lead AMED from April
March 26, 2025
- Pariet’s Nonprescription Versions Approved 6 Years after Discussions Start
March 25, 2025
- AMED President Mishima Hints at Resignation
March 25, 2025
- FPMAJ Prods Drastic Review of Fiscal Framework before Honebuto 2025
March 25, 2025
- Difficult to “Visualize” Distribution, Production Costs in NHI Prices: Minister
March 25, 2025
- MHLW Panel Discusses Ways to Promote Clinical Trials
March 24, 2025
- PMDA Issues Guidance for Pediatric Drug Development
March 24, 2025
- US Chamber Raises Japan’s Pharma Policy as Unfair Trade Practice, Prods Federal Govt for Action
March 19, 2025
- MHLW to Investigate Pharmaceutical Ad Regulations in US, Europe
March 18, 2025
- MHLW Council OKs Public Knowledge Filing for Anaemetro’s Pediatric Use
March 17, 2025
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Japan’s FY2026 drug pricing reform will, for the first time, apply the “G1” price cut rule for long-listed original biologics…
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…