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
- Japan OKs Coverage for Susmed Insomnia App, Shionogi ADHD Therapy App
May 15, 2026
- MHLW’s Mori Vows to Make Japan Pharma Market “More Attractive”
May 15, 2026
- MHLW Official Says US MFN Policy Could Be Taken Up by Chuikyo
May 15, 2026
- Oncolys’ Telomelysin Up for Japan Panel Review on May 21
May 15, 2026
- Japan to Launch CEA “Technical Discussions” under MHLW Research Group
May 14, 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…