Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Regulators Will Be Involved in Safety Data Transition for LLP Withdrawals: MHLW Official
Regulatory authorities will be involved in efforts to ensure the smooth transition of safety information and other data when original drug makers decide to pull their long-listed products (LLPs) off the market under a newly proposed LLP rule, a health…
To read the full story
Related Article
- Off-Year Revisions Should Be Confined to Limited Scope, JPWA Says at Chuikyo
November 30, 2017
- Exempt Some LLPs from New G1/G2 Price Scheme for Off-Patent Drugs: FPMAJ
November 30, 2017
- FPMAJ Chief Says Govt Proposal Is Fundamental Price Cut, Not Fundamental Reform: Chuikyo
November 30, 2017
- Maintain Drug Prices for Duration of Patent Coverage, PhRMA/EFPIA Stress at Chuikyo
November 30, 2017
- Japan, US, Europe Trade Groups Forge United Front against Govt PMP Plan, Supportive of Negative List: Chuikyo
November 30, 2017
REGULATORY
- Unpacking “MFN”: Japan Listed as Reference Country in US Pricing Models
April 16, 2026
- MHLW Taps Kawabata to Lead Drug Discovery Support Office
April 15, 2026
- MHLW Reviewing EMIS Data on Petro-Product Supply to Medical Institutions
April 15, 2026
- Japan Panel to Review Ferring Gene Therapy, Fujifilm Cell Product on April 20
April 14, 2026
- LDP, Ishin to Explore Role of Private Insurance in Reform Talks
April 14, 2026
In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…
Japan’s FY2026 drug pricing reform is set to usher in a new phase for the generics market, effectively bringing an…
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…