Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Japan to Revise PMD Law to Create Emergency Approval System, Final Paper Due Out by Year-End
The Japanese government is now set to create an emergency approval system based on “presumed efficacy,” with a health ministry panel giving the thumbs-up on December 22 to a paper paving the way for a legal amendment to this effect.…
To read the full story
Related Article
- MHLW Panel Urges Better Application of Emergency Approval
January 16, 2023
- LDP Lawmakers Want Specific Definitions for Emergency Approval Prerequisites
January 18, 2022
- Significance and Challenges around Proposed Emergency Approval Scheme, Eyes on Diet Debate
January 17, 2022
- Govt to Submit PMD Law Amendment Bill in Ordinary Diet Session to Introduce Emergency Approval
January 7, 2022
- MHLW Finalizes Paper on Emergency Approval System, Set to Submit Bill Next Year
December 28, 2021
- Panel OKs Outline of Emergency Approval System Based on “Presumed” Efficacy
December 6, 2021
- MHLW Eyes Emergency Approval System Based on “Presumed” Efficacy
December 2, 2021
- Japan Panel Discusses Safety, Immunity Rules for Envisaged Emergency Approval Scheme
November 19, 2021
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…