Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
Chuikyo Subcommittee OKs Basic SaMD Reimbursement Rule
The Central Social Insurance Medical Council’s (Chuikyo) medical materials subcommittee basically approved the outlines of the evaluation rules for software as a medical device (SaMD) under health insurance programs on November 12. Based on examples in the past, SaMD that…
To read the full story
Related Article
- Chuikyo OKs FY2022 Drug Pricing Reform Outline; Spillover Exclusion, Mega Seller Rule
December 23, 2021
- Public-Private Collaboration Needed to Refine SaMD Regulatory System
November 26, 2021
- Trade Groups Urges New Reimbursement Fee Evaluation for SaMD
August 26, 2021
- Chuikyo to Compile Proposal on SaMD Reimbursement by Year-End
August 5, 2021
- Chuikyo to Discuss Evaluation Rule for SaMD toward Next Reimbursement Reform
May 27, 2021
REGULATORY
- MHLW to Weigh Survey Data, Past Approach for FY2027 Revision: Official
September 10, 2026
- Chuikyo Reps Back Greater Transparency, but Lean toward Broader CEA Price Cuts
September 10, 2026
- OTC-Like Drug Charge Gets Prescription Field; No Double Charge with LLP Rule
September 10, 2026
- Defense Chief Seeks MHLW Help Securing Drugs for SDF
September 9, 2026
- PMDA Generic GMP Inspections a Real-World Test to Stem Startup Risks: Official
September 8, 2026
Japanese Prime Minister Sanae Takaichi has pledged to respond to the US most-favored-nation (MFN) drug pricing policy to safeguard timely…
We had just gotten off a call with a client in Europe, and we’d received a bit of an earful. “Philip,” the client pressed, “what can this candidate bring to us? We know what he does, but what has he…
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…