Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
ORGANIZATION
Osaka-Based NPO to Take on Outsourcing of GMP Compliance Audit on Drug Substance Makers
An Osaka-based non-profit organization is set to launch an outsourcing service in mid-March to audit drug substance makers’ compliance with Japanese Good Manufacturing Practice (GMP) requirements on behalf of pharmaceutical companies. By tapping the expertise of GMP-savvy retirees of regulatory…
To read the full story
ORGANIZATION
- EFPIA Report Calls Japan a “Cautionary Tale” in 10-Country Biopharma Strategy Review
March 2, 2026
- Pharma Takes Harsh View of FY2026 Pricing Reform: Policy Group Survey
February 24, 2026
- JPMA to Push Govt to Scrap Market-Based Drug Price Revisions
February 20, 2026
- Pharma Group Looks to Growth Strategy under Takaichi after Election Win
February 10, 2026
- Pharma Groups Call for Faster Diagnosis and R&D for Intractable, Rare Diseases
February 9, 2026
The launch of Elevidys has opened the door to gene therapy for DMD, but research into new treatments is already…
I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…
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…