Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Experts Support Plan to Seize Improperly Earned Revenue as in Diovan Case: HSC
A number of experts on June 7 threw their support behind a plan to create a system that would empower the government to take away revenues from drug makers if they were improperly earned, such as through misleading advertising prohibited…
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 Proposes Introduction of Administrative Fines for Improperly Earned Revenues
November 27, 2018
- Govt Should Screen Drug Promotion Material, Scope of Information Provided: HSC Member
June 8, 2018
- Industry Asked for Legislation for Conditional Early Approval and Sakigake Designation Scheme: MHLW Panel
May 11, 2018
- MHLW Panel Starts Discussions on PMD Law Amendment; Will First Verify Results of Previous Amendment
April 12, 2018
- MHLW Panel to Kick Off Debates on Amendment of Pharmaceuticals and Medical Devices Law
April 5, 2018
REGULATORY
- Japan Panel Backs Daiichi’s MMR Vaccine, Haihe’s PI3Kα Inhibitor, MSD’s HIV Med
March 3, 2026
- MHLW Revises Guidance on Pediatric Development Plans under Amended PMD Act
March 3, 2026
- MHLW Details New Operational Rules for Conditional Approvals from May
March 3, 2026
- MHLW Seeks Sponsors to Develop 8 “Drug-Loss” Products
March 2, 2026
- WG Members Urge Domestic Biologic Production as National Growth Strategy
March 2, 2026
Japan’s FY2026 drug pricing reform will, for the first time, apply the “G1” price cut rule for long-listed original biologics…
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…