REGULATORY

Japan Jittery over Mass Layoffs at FDA, though HHS Says Reviewers Won’t Be Affected

By Ken Yoshino March 31, 2025
Officials of the Japanese government and pharmaceutical industry are wringing their hands over the potential ramifications of recently announced job cuts of 3,500 at the US FDA due to the sweeping magnitude of the reduction, though reviewers are said to…

To read the full story

REGULATORY

By Shunsuke Tani

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…

By Kohei Hori

As Japan’s budget season draws near, the Ministry of Finance (MOF) has renewed its push for a full-scale “off-year” drug…

By Ken Yoshino

Japan is pressing ahead with broader drug price cuts under its cost-effectiveness assessment (CEA) system, despite lingering questions over the…

By Kohei Hori

Members of a key reimbursement policy panel on October 28 raised no objections to expanding drug makers’ access to deliberations…

By Takashi Ebisawa

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…