Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MHLW Proposes Tightening 40% Entry Pricing for New Oral Generics
The Ministry of Health, Labor and Welfare (MHLW) on November 29 proposed a more stringent application of the current 40% entry price rule for first oral generics towards the FY2024 drug pricing reform. Under the current rule, first oral generics…
To read the full story
Related Article
- MHLW to Disclose Company Names under Generic Index Rule Possibly in FY2026
December 19, 2024
- Discussions on Generic Company Indices Make Headway towards Full Rollout in Next Revision
December 13, 2024
- Chuikyo Supports Full Rollout of Company Indices for Generics Manufacturers
November 7, 2024
- 120 APIs/Specs to Get Higher-than-Peer Prices with Generic Company Indicators: MHLW Simulation
December 14, 2023
- Pharma Industry Backs MHLW Proposal to Scrap PMP Indicators: Chuikyo Hearing
December 7, 2023
- MHLW Pushes Boosted Launch Premiums, Slew of Other Pricing Steps to Reward Innovation
November 30, 2023
- No Consensus on PMP Company Criteria, Likely Review for Spillover Rule: Chuikyo
November 30, 2023
- Japan to Adopt Generic Company Indices for Drug Pricing on Pilot Basis from FY2024
November 20, 2023
- Revisit 25-Plus-Year Listing Requirement for Essential Drugs: Chuikyo Members
November 13, 2023
REGULATORY
- MHLW Issues Q&A on Conditional Approval System
May 1, 2026
- Panel Backs Proposal to Allow Antibody Drugs Like Beyfortus in NIP
May 1, 2026
- METI Clarifies Naphtha Comments, Reaffirms Medical Priority
April 30, 2026
- Japan Minister Rules Out Full Self-Pay for OTC-Like Drugs
April 30, 2026
- Govt’s Bio-WG Wraps Up Biopharma Investment Roadmap Draft
April 30, 2026
Japan’s pharmaceutical industry is undergoing a structural shift in its workforce, with the role of sales reps shrinking while production…
In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…
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…