On paper, things should be looking up for Japan’s pharmaceutical wholesalers. Industry expectations are mounting that the average gap between NHI and market prices will narrow further in FY2026 from the previous year’s record low of 4.8%.A shrinking gap should…
REGULATORY
MHLW OKs First Generics for Tracleer, 6 Other APIs towards December Listing
The Ministry of Health, Labor and Welfare (MHLW) on August 15 approved first generics for seven active pharmaceutical ingredients (APIs) towards their reimbursement listing in December, including those for Actelion Pharmaceuticals’ pulmonary arterial hypertension (PAH) drug Tracleer (bosentan). Tracleer is…
To read the full story
Related Article
- Talion AG, 2 Other APIs Skip December Gx Listing
December 8, 2016
- First Generics for 5 APIs to Join NHI Price List on Dec. 9
December 8, 2016
- Kipres Generics Might Add Bronchial Asthma Indication before December Listing
October 21, 2016
- Kipres/Singulair to Face Generic Onslaught in Dec.; Competition to Hit Tracleer, Too
August 4, 2016
REGULATORY
- PMDA Sees Little Need for Separate Dosage Form Category for Mini-Tablets
November 11, 2026
- Japan Eyes Nationwide Probe into Wartime Drug Trials on Leprosy Patients
November 11, 2026
- Kyowa Kirin’s Libmeldy Gene Therapy Now in Line for Japan Approval
November 10, 2026
- Astellas Employee Jailed for Espionage in China Set for December Release
November 10, 2026
- Nearly 1,200 COVID Vaccine Injury Relief Claims Still Await Review in Japan
November 10, 2026
Tariffs have been a defining feature of US trade policy under President Donald Trump’s second administration. Since Trump unveiled his “reciprocal” tariff policy in April 2025, the landscape has shifted repeatedly.In February 2026, the US Supreme Court invalidated tariffs imposed…
As Japan’s budget season draws near, the Ministry of Finance (MOF) has renewed its push for a full-scale “off-year” drug…
Japan will trim the NHI price of Eli Lilly Japan’s Alzheimer’s treatment Kisunla (donanemab) by 3.93% under the cost-effectiveness assessment…
Japan is set to add 16 new drugs to its NHI reimbursement price list on November 13, including a subcutaneous…
Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
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…