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
- Update: DMD Gene Therapy Elevidys Cleared for NHI Listing at 305 Million Yen
February 13, 2026
- MHLW Orders Label Revisions for Vyxeos, Inlyta, Imbruvica, and More Drugs
February 13, 2026
- MHLW Orders Label Revisions for Sulfite-Containing Medical Products
February 13, 2026
- PMDA Urges Proper Use of Colchicine, Advises against High-Dose Administration
February 12, 2026
- PMDA to Offer Priority Consultations for Overseas Startups
February 12, 2026
Japan’s health and finance ministers agreed late last year to go ahead with an “off-year” drug price revision in FY2027,…
The Japanese healthcare sector is experiencing rapid growth, demanding a highly skilled and diverse workforce. However, finding and attracting the best talent in this competitive market presents significant challenges.Enter AI. With the rise of AI-powered tools, healthcare organizations can revolutionize…
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…