Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Japan Enacts Bill to Amend Regenerative Medicine Safety Act, Clinical Trial Act
Japan’s Diet passed into law a bill to amend the regenerative medicine safety act and the clinical trials act by a majority vote at an Upper House plenary session on June 7. The now-endorsed amendment of the regenerative medicine act…
To read the full story
Related Article
- MHLW to Present Detailed Criteria for Exclusion from “Specified Clinical Trials”
August 20, 2024
- Certain Jabs to Be Exempted from Regenerative Medicine Safety Act to Facilitate Travel Vaccination
August 20, 2024
- Japan Cabinet OKs Bill to Amend Regenerative Medicine Safety Act, Clinical Trial Act
March 7, 2024
- LDP Panel OKs Bill to Amend Regenerative Medicine Safety Act, but Lawmakers Fret Lack of Ban on “Designer Babies”
February 22, 2024
- Japan’s Diet Kicks Off 150-Day Regular Session, MHLW Plans 4 Bills
January 29, 2024
- MHLW’s Planned Bill Would Exclude Certain Programs from “Specified Clinical Trials”
January 16, 2024
- MHLW Plans to Submit 4 Bills to This Year’s Ordinary Diet Session
January 16, 2024
REGULATORY
- Japan Officially Eases Trial Recruitment Rules; Industry Welcomes Move
April 1, 2026
- MHLW Updates Q&A on Use of Registry Data in Drug Applications
April 1, 2026
- Japan Panel Designates Two Ebola Therapies for Early Approval Pathway
April 1, 2026
- MHLW, METI Launch Joint Task Force to Safeguard Medical Supply Chains
April 1, 2026
- Japan Urges Priority Supply of Petroleum-Based Materials for Medical Devices
March 31, 2026
Strategic Talent Acquisition in the Japanese Life Sciences Sector: Your Market Intelligence Briefing
Focus: How to Get the Talent You Need in a Tough MarketThe Japanese life sciences sector presents a challenging landscape for global companies. To succeed, you must move beyond reactive hiring and adopt a truly strategic talent acquisition model. Our…
Japan’s FY2026 drug price revision, officially announced on March 5, has landed poorly with the pharmaceutical industry — and the…
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…