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 Needs Guidelines on Conditional Approval for Regenerative Medicines: Lawmakers
April 7, 2023
- Tokyo Likely to See Next COVID Spike around First Half of May: Experts
April 7, 2023
- MHLW to Make Case-by-Case Decisions on Use of “Specified Clinical Research” Data in Regulatory Filings
April 6, 2023
- Expert Panel Questions Requirement for Generic Listing in All Versions
April 5, 2023
- Expert Panel Mixed on Macroeconomic Indexing of Drug Cost; Govt Urged to Quit Targeting Pharma for Savings
April 5, 2023
- Antibiotics against CRE Chosen for Japan’s Revenue-Guarantee Pilot Project
April 5, 2023
- Health Minister Vows Transparency in Vaccine Purchase after Audit Report
April 4, 2023
- MHLW Issues Guidance on eConsent in Clinical Trials
April 4, 2023
- 32 Hypertension Meds under PMDA Safety Review for Women of Childbearing Potential
April 3, 2023
- Suprapartisan Lawmakers’ League Discussing Bill to Establish Dementia Law
March 31, 2023
- LDP League Asks Health Minster for Proper Insurance Coverage for Patches
March 31, 2023
- AMED’s “CANNDs” Set for Full Rollout in FY2023, but Panel Members Want Wider Range of Data to Fuel Drug Discovery
March 31, 2023
- Japan to Allow Drone Deliveries of Drugs When Appropriate, Including Powerful Meds
March 29, 2023
- Panel OKs 3 Products for 1st SaMD Priority Review Designations
March 29, 2023
- Japan Diet Enacts Record Budget for FY2023
March 29, 2023
- Ipsen’s Fidrisertib, Chugai’s Faricimab and 2 More APIs Get Orphan Tags in Japan
March 29, 2023
- Japan Approves Wegovy, Omvoh, FluMist, Entyvio SC and More
March 28, 2023
- 5 Wholesalers Ordered to Pay 627 Million Yen in Surcharge over Kyushu Bid-Rigging
March 27, 2023
- Public Comments 2 to 1 in Favor of Approving Abortion Pill: MHLW
March 27, 2023
- MHLW to Review Application of Emergency Approval System after COVID Downgrade
March 27, 2023
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…