Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
Sakigake Status Should Not Be Granted to Novartis Products until It Takes Prevention Measures for Approval Delay: Pharma Bureau Chief
Mitsuaki Kamata, director general of the Pharmaceutical Safety and Environmental Health Bureau, urged Novartis Pharma to seriously reflect on its flaws in the review process for sakigake-designated Zolgensma (onasemnogene abeparvovec) whose approval was delayed. The company’s products should be made…
To read the full story
Related Article
- Yescarta Sails through PAFSC Review; Panel Roughly OKs Novartis’ Corrective Measures after Zolgensma Delay
December 4, 2020
- Japan Rolls Out Full-Fledged Sakigake System, Designations 2 Times a Year with Tougher Revocation Rules
September 1, 2020
- Will Zolgensma Delay Spur Revision of Sakigake Designation System?
June 11, 2020
- Novartis’ Flawed and Delayed Inquiry Responses in Zolgensma Review “Extremely Unusual”: PMDA Report
April 16, 2020
- Novartis Japan Chided over Flawed Zolgensma Data, Delayed Responses
April 8, 2020
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…