Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Consolidate IRBs to Streamline Clinical Trials in Japan: Govt Working Group
Members of a working group under the government’s regulatory promotion panel on March 7 voiced the need for consolidating institutional review boards (IRBs) to boost the efficiency of clinical trials in Japan. In Japan, the obligation for each medical institution…
To read the full story
Related Article
- MHLW Official Urges Proper IRB Selection under New GCP Rules
June 12, 2026
- Japan Panel Slams MHLW’s 80% Single-IRB Target as Too Low
March 24, 2026
- MHLW Pushes Back GCP Ordinance Revision to Summer
February 3, 2026
- Japan Mulls Amendment of GCP Ordinance, Making Single IRBs a Rule
April 3, 2025
- Include Single IRB Policy in GCP to Accelerate Trials: EFPIA Official
February 10, 2025
- Japan to Obligate Single IRB in Multi-Center Clinical Trials That Use Competitive Funds
June 24, 2024
- Make Single IRB Mandatory in Multi-Center Trials That Use Competitive Funds: Deregulation Panel
June 4, 2024
REGULATORY
- Government Unveils Four-Chapter Outline for 2026 Honebuto
June 26, 2026
- LDP, Ishin Leave Chuikyo Reform to Party Negotiators after Talks Stall
June 26, 2026
- Japan Targets Global-Level Growth for Domestic Patented Drug Market
June 25, 2026
- Paxlovid, Awiqli Braced for NHI Price Cuts after CEAs
June 25, 2026
- Drug Pricing to Be Applied to Oncolys Oncolytic Virus Therapy
June 25, 2026
Let’s face it: in today’s world, changing jobs is a normal part of a successful career. But if it’s so normal, why does it feel so hard? For many people, the idea of leaving their current role brings a heavy…
Japan’s leading pharmaceutical wholesalers are bracing for a second consecutive year of profit declines, underscoring the growing challenge of generating…
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…