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 Officially Drops Japanese PI Requirement before Global Trial Entry
December 26, 2023
- Japan Filing within 3 Months of Global Submission Eligible for Sakigake: MHLW
December 26, 2023
- Japan Ends Supply of Takeda/Novavax’s COVID Jab, 7.14 Million Doses Discarded
December 26, 2023
- Kaigen Pharma Hit by Suspension Order for Decades of Illicit Manufacturing
December 25, 2023
- MHLW Budget Hits Record High at 33.8 Trillion Yen, Ups Funding for Drug Innovation
December 25, 2023
- (Update) Sawai Slapped with Biz Improvement Order over Rigged Quality Tests
December 25, 2023
- MHLW Announces “Innovation Box” Tax Regime: FY2024 Reform
December 25, 2023
- Japan Approves Label Expansions for Rexulti, Rituxan, and More
December 25, 2023
- Japan Grants Orphan Tags to Keytruda, Teprotumumab, and 3 More Drugs
December 25, 2023
- Ryukaikon OKs Revised Distribution Guidelines, Pharmas Urged to Explain Rationale of Solo Wholesaler Policy
December 22, 2023
- Japan Aims for 80% Unit-Price Negotiation Rate by FY2026-End: Reform Timeline
December 22, 2023
- Chuikyo OKs Outline of FY2024 Drug Pricing Reform; No Unprofitability Re-Pricing for 7%-Plus Price Gap
December 21, 2023
- Health Ministry Panel OKs Inclusion of 5-in-1 Jab in NIP from Next April
December 21, 2023
- Japan to Roll Out New LLP Coverage Rule in October; 18 Billion Yen Saving Eyed for FY2024
December 21, 2023
- Masaki Ogushi Promoted to Chief of LDP’s Health Division
December 21, 2023
- Japan to Cut Drug Prices by 0.97% on Healthcare Cost Basis in FY2024
December 20, 2023
- Gist of FY2024 Drug Pricing Reform
December 20, 2023
- MHLW to Post Medical Facilities Providing Leqembi Treatment on Website
December 18, 2023
- Japan to Raise Medical Fee by 0.88%, Cut Drug Costs by Around 1% in FY2024
December 18, 2023
- Chuikyo Split on Copay Rate under Elective Care Scheme; Political Decision Likely over 1/2 or 1/4
December 18, 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…