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
PMDA Generic GMP Inspections a Real-World Test to Stem Startup Risks: Official
Japan’s upcoming shift of GMP inspections for newly approved generics to the Pharmaceuticals and Medical Devices Agency (PMDA) will serve as a real-world test of whether closer coordination between regulatory reviews and manufacturing oversight can head off quality problems at…
To read the full story
Related Article
- Japan, US Launch Talks on Pharma GMP MRA to Ease Inspection Burden
July 3, 2026
- MHLW Seeks to Raise Quality of Prefectural Generic GMP Inspections
September 8, 2025
- Japan’s Parliament Enacts Bill to Amend PMD Act
May 15, 2025
- PMDA-Led Inspections Will Help Straighten Up Generic Makers: MHLW Councilor
September 6, 2024
- MHLW Sets Out to Beef Up Inspector Skills with Nationwide Sharing of GMP Reports
February 29, 2024
REGULATORY
- Kyowa Kirin’s Libmeldy Gene Therapy Now in Line for Japan Approval
November 10, 2026
- Astellas Employee Jailed for Espionage in China Set for December Release
November 10, 2026
- Nearly 1,200 COVID Vaccine Injury Relief Claims Still Await Review in Japan
November 10, 2026
- LDP League Seeks Drug Pricing Revamp to Support Patches
November 10, 2026
- Keytruda SC Tops New NHI Listing Round with 75 Billion Yen Sales Outlook
November 9, 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…