Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
120 APIs/Specs to Get Higher-than-Peer Prices with Generic Company Indicators: MHLW Simulation
A total of 120 APIs/specifications, or 190 products, are expected to receive NHI prices higher than those given under the current rule in the proposed pilot-based evaluation of generic manufacturers using company indicators, a health ministry simulation revealed. The Ministry…
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
- Chuikyo OKs Outline of FY2024 Drug Pricing Reform; No Unprofitability Re-Pricing for 7%-Plus Price Gap
December 21, 2023
- Gist of FY2024 Drug Pricing Reform
December 20, 2023
- MHLW Proposes Tightening 40% Entry Pricing for New Oral Generics
November 30, 2023
- Japan to Adopt Generic Company Indices for Drug Pricing on Pilot Basis from FY2024
November 20, 2023
- No Objections to Reflecting Company Indices for Generic Supplies in Pricing: Chuikyo
October 30, 2023
- MHLW Panel Proposes Assessing Generic Makers’ Efforts toward Stable Supplies, Reflecting Results in Pricing
October 12, 2023
REGULATORY
- Japan Panel Backs Daiichi’s MMR Vaccine, Haihe’s PI3Kα Inhibitor, MSD’s HIV Med
March 3, 2026
- MHLW Revises Guidance on Pediatric Development Plans under Amended PMD Act
March 3, 2026
- MHLW Details New Operational Rules for Conditional Approvals from May
March 3, 2026
- MHLW Seeks Sponsors to Develop 8 “Drug-Loss” Products
March 2, 2026
- WG Members Urge Domestic Biologic Production as National Growth Strategy
March 2, 2026
Japan’s FY2026 drug pricing reform will, for the first time, apply the “G1” price cut rule for long-listed original biologics…
I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…
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…