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
MHLW Reveals Details of New Withdrawal Rules for Off-Patent Branded Drugs
The Ministry of Health, Labor and Welfare (MHLW) issued a notification on March 29 to provide details on its withdrawal rules for so-called “G1 LLPs (long-listed products),” or off-patent brand name drugs with an 80%-plus generic rate that will face…
To read the full story
Related Article
- It’s Time to Revise G1 Withdrawal Scheme, Rule Likely to Be Applied to Only a Few Products: FPMAJ
June 14, 2022
- Pfizer, Bayer to Pull Plug on “G1” Products with High Generic Erosions
March 5, 2021
- Several Brand-Name Drug Makers Intend to Withdraw “G1” LLPs
July 4, 2018
Related LEXICON
-
G1/G2 RuleG1/G2ルールMarch 9, 2018
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…