Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MHLW Compiles Proposal for PMD Law Amendment, Eyes Diet Submission of Related Bill Next Year
The Ministry of Health, Labor and Welfare (MHLW) has drafted a paper outlining a series of proposals to amend the Pharmaceuticals and Medical Devices (PMD) Law, which include the legislation of its conditional approval and sakigake systems, and administrative fines…
To read the full story
Related Article
- MHLW Seeks Opposition Party Understanding on Removal of Officer Change Order Provision from Amendment Bill for PMD Law
March 15, 2019
- Dismissal Order Provision Erased from PMD Law Amendment Bill
March 14, 2019
- MHLW Likely to Tweak PMD Law Amendment Bill as Lawmaker Frowns on Order to Change Pharmaceutical Affairs Officer
March 13, 2019
- LDP Wraps Up Review on Bill to Amend PMD Law; Cabinet OK Eyed in Mid-March
March 8, 2019
- MHLW to Impose Administrative Fines Only on Misleading Ads, Eyes 4.5% Charge: PMD Law
February 28, 2019
- MHLW to Give Enough Preparation Time for Local Govts before New PMD Law Takes Effect
January 21, 2019
- Amendment of PMD Law Will Be Top Priority in 2019: MHLW Bureau Chief Miyamoto
January 8, 2019
REGULATORY
- MHLW Lifts Part of Approval Conditions for Takeda’s Vyvanse
June 9, 2026
- Drug Makers Seek Govt Support for Immunoglobulin Plant Investments: LDP Hearing
June 9, 2026
- Japan Govt Likely to Slim Down Honebuto, but Details Remain Elusive
June 8, 2026
- Leqembi, Kisunla Labels Revised to Strengthen ARIA Monitoring
June 8, 2026
- Japan Tightens Oversight of Mounjaro Resales: Health Minister
June 8, 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…