Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Quality Assurance and Lag/Loss Fight to Form Pillars of PMD Act Amendment
A Japanese health ministry panel on December 26 wrapped up its discussions on the next amendment of the Pharmaceuticals and Medical Devices (PMD) Act. The proposed revision encompasses a series of changes aimed at ensuring the quality and stable supply…
To read the full story
Related Article
- Japan Cabinet Approves Bill to Amend PMD Act
February 13, 2025
- PMD Act Set for Amendments Covering Issues Unaddressed over Past Decade: MHLW Official
February 4, 2025
- Draft Bill to Amend PMD Act Up for LDP Review on Jan. 27
January 23, 2025
- MHLW Preparing to Submit Bill to Amend PMD Act in Mid-February
January 17, 2025
- MHLW Publishes Panel Report on PMD Act Amendment
January 14, 2025
- Japan to Require Drug Makers to Set Up Legal Post of “Stable Supply Manager”
November 29, 2024
- MHLW Panel Discusses Ways to Rationalize Ethical Narcotics Distribution
July 30, 2024
- MHLW Panel Sets Topics for PMD Act Amendment; Pediatrics, Drug Loss on Agenda
April 19, 2024
REGULATORY
- LDP Pharma Project Team to Compile Roadmap Proposals after Industry Hearings
April 17, 2026
- DPJ Leader to Urge Drug Price Hikes, “Freeze” on Off-Year Revisions
April 17, 2026
- War-Linked Supply Impact Cases Climb to 34 as Japan Steps Up Response
April 17, 2026
- Meiji Pharma Chair Prods Drug Price Hikes as War Drives Up Costs: Diet
April 17, 2026
- Japan Eases Documentation Requirements for Excipients Listed in Foreign Pharmacopoeias
April 17, 2026
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 FY2026 drug pricing reform is set to usher in a new phase for the generics market, effectively bringing an…
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…