Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
“Annual Reports” Allowed for CMC Changes with Minimal Impact: MHLW
Drug manufacturers will be allowed to submit “annual reports” rather than the current “minor change notifications” when their proposed post-approval manufacturing changes have a relatively minor impact on product quality, according to the health ministry. This rule change is included…
To read the full story
REGULATORY
- LDP Panel Approves Honebuto Proposal on Preventive Healthcare
June 2, 2026
- LDP Patch League to Seek Drug Price Support in Honebuto Proposal
June 2, 2026
- Novo’s Wegovy Nears Japan Approval as First MASH Therapy
June 1, 2026
- Japan Enacts Reform Bill Paving Way for OTC-Like Drug Charges
June 1, 2026
- Four Pharma Secondees Join AMED Drug Discovery Initiative
June 1, 2026
Japan is finally launching technical discussions on its cost-effectiveness assessment (CEA) system. A health ministry-funded research group is set to…
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…