Tariffs have been a defining feature of US trade policy under President Donald Trump’s second administration. Since Trump unveiled his “reciprocal” tariff policy in April 2025, the landscape has shifted repeatedly.In February 2026, the US Supreme Court invalidated tariffs imposed…
REGULATORY
Japan to Obligate Single IRB in Multi-Center Clinical Trials That Use Competitive Funds
The Japanese Cabinet on June 21 gave its approval to the annual implementation plan for regulatory reform, in which it called for making the use of a single institutional review board (IRB) mandatory in publicly funded joint drug research. The…
To read the full story
Related Article
- Govt’s New Capitalism Council Proposes Extending Scope of Mixed-Billing Scheme
June 11, 2024
- Make Single IRB Mandatory in Multi-Center Trials That Use Competitive Funds: Deregulation Panel
June 4, 2024
- Expand Mixed-Billing Scheme to Cover Gene Panel Test: LDP Committee Proposal
May 31, 2024
- Expand Mixed-Billing Scheme, Use of Private Payers: LDP Healthcare Reform Team
May 20, 2024
- Apply Elective Care Scheme to Original Biologics with Biosimilars: Professor to LDP
May 10, 2024
- New LDP Project Team Boots Up for Healthcare Transformation
May 8, 2024
- Consolidate IRBs to Streamline Clinical Trials in Japan: Govt Working Group
March 11, 2024
REGULATORY
- Japan Nudged to Probe Wide Gaps in Biosimilar Uptake
November 6, 2026
- Japan Eyes Multi-Year Investment Support for Wholesalers in FY2027 Budget
November 6, 2026
- Japan Poised to Broker Generic Firms’ Product Consolidation Talks
November 6, 2026
- Japan Issues Guidance on AI Model Use in Drug Manufacturing, Quality Control
November 6, 2026
- JPMA Urges Foreign Price Rule Overhaul to Address US MFN Policy: LDP Hearing
November 5, 2026
As Japan’s budget season draws near, the Ministry of Finance (MOF) has renewed its push for a full-scale “off-year” drug…
Japan is pressing ahead with broader drug price cuts under its cost-effectiveness assessment (CEA) system, despite lingering questions over the…
Members of a key reimbursement policy panel on October 28 raised no objections to expanding drug makers’ access to deliberations…
Eli Lilly’s breast cancer drug Imulrio (imlunestrant) is finally joining Japan’s NHI price list on October 14, nearly 300 days…
Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
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…