Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
ACADEMIA
NCC Doctor Hails MHLW’s Policy on Use of Clinical Research Data in Regulatory Filing
A doctor of the National Cancer Center Hospital well-versed in operating clinical research has welcomed a recent move by the Japanese health ministry to provide its basic policy for the use of data from so-called “specified clinical research” in regulatory…
To read the full story
Related Article
- MHLW to Make Case-by-Case Decisions on Use of “Specified Clinical Research” Data in Regulatory Filings
April 6, 2023
- Label Expansion for TS-1, Enhertu and More in Line for November Approval
November 1, 2022
- MHLW Presents Policy for Use of “Specified Clinical Research” Data in Regulatory Submissions
April 4, 2022
ACADEMIA
- NCC Launches First Japan Trial for CP Inhibitor-Related Liver Dysfunction
April 27, 2026
- Dementia Drugs See Modest Uptake in Japan amid Eligibility Limits, Safety Concerns
April 9, 2026
- Cancer Drug Supply Risks Spur Calls for Pricing Reform: JSMO
March 31, 2026
- Japan Ophthalmology Society Flags Off-Label Concerns Ahead of Upneeq Launch
March 30, 2026
- Real-World Study Backs Lecanemab Safety, 90% Stay on Treatment
March 25, 2026
Japan’s pharmaceutical industry is undergoing a structural shift in its workforce, with the role of sales reps shrinking while production…
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 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…