Japan plans to revise its definition of “vaccines of high development priority.” The Ministry of Health, Labor and Welfare’s (MHLW)…
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 Orders Label Revisions for Lixiana, Keytruda, and More Drugs
January 30, 2025
- Pfizer’s Litfulo Braced for Price Cut after Cost-Effectiveness Assessment
January 30, 2025
- MHLW Panel Finalizes NIP Inclusion of Shingles Jabs, OKs New Basic Immunization Plan
January 30, 2025
- FPMAJ Reports Detailed Results of Blanket Self-Inspections for Generic Firms
January 29, 2025
- Celltrion Is Developer of Japan’s Third Stelara Biosimilar in the Wings
January 29, 2025
As CEO of Morunda, I had the privilege of interviewing Bill Schuster, Country Manager of Viatris in South Korea. Our conversation delved into the multifaceted nature of leadership in the healthcare industry, exploring challenges, successes, and the power of authenticity.A…
A Japanese health ministry panel on December 26 wrapped up its discussions on the next amendment of the Pharmaceuticals and…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s key reimbursement policy panel on December 25 approved an outline of the FY2025 drug price revision, finalizing plans to…
For the first time in many years, Japan appeared to have pivoted to a pro-innovation path with the FY2024 drug pricing reform. All eyes were apparently on this course change as seen in this year’s most-read story list, though the…
A Japanese health ministry panel discussing the generic industry structure on May 22 put together a report in which it…
A Japanese health ministry study group focused on pharmaceutical regulations on March 21 agreed on a policy to encourage the…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…
The Japanese health ministry’s expert panel tasked to discuss comprehensive policies for the rapid and stable supply of pharmaceuticals generally…