Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
ICH-S9 Guideline to Apply to Non-Clinical Studies for “Serious Malignancies”
The International Council for Harmonization’s (ICH) S9 Guideline (Nonclinical Evaluation for Anticancer Pharmaceuticals) will apply to drugs that are intended to treat cancer in patients with serious and life threatening malignancies, and it will not determine the thresholds of seriousness…
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REGULATORY
- MFN Now a Factor in Japan’s Drug Pricing Debate: New Pharma Policy Chief
September 11, 2026
- 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
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…