Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
PMD Act Set for Amendments Covering Issues Unaddressed over Past Decade: MHLW Official
The proposed amendments of the Pharmaceuticals and Medical Devices (PMD) Act, soon up for Diet deliberations, are intended to address regulatory and corporate governance issues that have been left unresolved over the past decade, a senior health ministry official says.…
To read the full story
Related Article
- Japan Cabinet Approves Bill to Amend PMD Act
February 13, 2025
- New Govt Fund for Innovative Drugs: Twists, Turns, and Hope
February 10, 2025
- LDP-OK’ed Bill for PMD Act Amendment Specifies Launch of Innovative Drug Fund
January 28, 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
- Quality Assurance and Lag/Loss Fight to Form Pillars of PMD Act Amendment
December 27, 2024
REGULATORY
- 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…