The approval of Aβ-clearing antibodies like Leqembi (lecanemab) and Kisunla (donanemab) marked a landmark shift toward disease-modifying therapies in Alzheimer’s,…
HOME > REGULATORY
REGULATORY
- Japan, EU to Expand GMP MRA to Cover Europe; Types of Products Covered Might also Be Expanded
February 8, 2016
- Editor’s Pick: Five Healthcare Policy News Headlines for January
February 5, 2016
- MHLW Won’t Rule Out Single-Patient Humanitarian Trials: Official
February 5, 2016
- Council OKs Public Knowledge-Based Application for Capecitabine as Adjuvant Chemotherapy for Rectal Cancer
February 5, 2016
- Chuikyo Ends Debate on FY2016 Reimbursement Policy Reform; Price-Based Penalty for Suspended Firms Not in Recommendation
February 4, 2016
- NCC, PMDA Forge Comprehensive Collaboration Pact
February 3, 2016
- MHLW Panel Backs Approval of Novartis’s Melanoma Drugs
February 2, 2016
- MHLW Allows Shipment of Kaketsuken’s Hep A, B Vaccines
February 2, 2016
- Chuikyo Reps Want Price-Based Penalty Added to Supplementary Opinions for FY2016 Reform Proposal, MHLW Expresses Caution
February 1, 2016
- Govt Says It’s “Not Recommending” Research-Driven Makers to Become Generic Makers, It’s One Option
February 1, 2016
- MHLW Sends Alert on Opdivo’s Fulminant Type 1 Diabetes Risk
February 1, 2016
- Suspended-but-Shipped Drugs Should Face 20% Price Cut, Chuikyo Member Says amid Kaketsuken Fuss
January 28, 2016
- MHLW in Final Stages of Study Aimed at Drafting Guidelines on Nucleic Acid Therapeutics; Final Report Due Out FY2016-End
January 28, 2016
- “Huge-Seller” Re-Pricing Created due to Drugs with Huge Financial Impact: Govt
January 27, 2016
- New Basic Guidelines for Hepatitis Measures to Promote Drug Discovery for Hep B
January 27, 2016
- Sakigake Products Added to Scope of Priority Review: MHLW Notification
January 26, 2016
- MHLW Revises GCP Ordinance to Incorporate New Compassionate Use Scheme
January 26, 2016
- Govt Panel Says New Growth Strategy Should Embrace Further Efforts to Fuel Drug Development
January 26, 2016
- PAFSC First Committee to Discuss Add’l Indications for Rituxan, Cymbalta on Feb. 5
January 26, 2016
- Japan Compassionate Use Gets Underway Covering Sakigake-Requested Products, Orphans
January 26, 2016
ページ
PHARMA JAPAN welcomes JETRO New York’s Shunsuke Tani as a guest columnist. In occasional contributions, Tani will share his perspectives on US pharmaceutical policy, industry developments, and life in America, drawing on his firsthand experience in the US.---Hello from New…
Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
Japanese Prime Minister Sanae Takaichi said on October 14 that the government will consider the necessary measures for the FY2027…
Eli Lilly’s breast cancer drug Imulrio (imlunestrant) is finally joining Japan’s NHI price list on October 14, nearly 300 days…
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…