Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
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REGULATORY
- Tailwind for Prevenar 13? Vaccine Panel Members Up for Its Use in High-Risk Elderly
September 11, 2018
- JPMA Official Hails MHLW Discussions on Use of “Specified Clinical Research” Data in Application Dossiers
September 10, 2018
- 4th Sakigake Invitation to Start on October 1: MHLW
September 10, 2018
- MHLW to Promote Optimization of Plasma Fraction Product Transactions: New Blood Product Chief
September 7, 2018
- MHLW to Discuss Measures to Strengthen Governance among Blood Collection Operators through Amendment of Blood Law
September 7, 2018
- MHLW to Embrace Communications with Industry on Drug Pricing Overhaul: Medical Economics Chief
September 6, 2018
- Data Protection Period Extended for Feburic, Cubicin: MHLW
September 6, 2018
- Otezla, Ceftriaxone Labels Revised: MHLW Safety Bulletin
September 5, 2018
- New “Center of Excellence” to Be Set Up in US to Train Regulators from APEC Region, Promote Multiregional Clinical Trials
September 5, 2018
- India Plans to Exempt Domestic Study for Japan-Approved Drugs
September 4, 2018
- MHLW, METI Seek 3-Year Extension for Temporary R&D Tax Credit Measures
September 3, 2018
- FY2019 Revision Should Cover Only “Half a Year’s Worth” of Price Tweaks, MHLW Insurance Chief Says for Clarification
September 3, 2018
- April 2019 Price Cut Wouldn’t Fit the Purpose of Tax Tweak: MHLW Insurance Chief
August 31, 2018
- MHLW to Steadily Promote Pharma Industry through Comprehensive Strategy: New Health Policy Chief
August 31, 2018
- Kyorin’s OAB Drug Vibegron and More Clear MHLW Panel; Official Nod Anticipated September
August 31, 2018
- Panel Gives Blessing for Pfizer’s Lorlatinib, Astellas AML Drug; Approval Expected in September
August 30, 2018
- MHLW to Request Record Budget of Nearly 31.9 Trillion Yen for FY2019
August 30, 2018
- MHLW Panel Backs Orphan Status for SMA Gene Therapy, CAR-Ts
August 30, 2018
- MHLW Discussing Use of Data from “Specified Clinical Research” in Application Dossiers, Will Issue Preliminary Conclusions by March
August 29, 2018
- Chuikyo Might Take Up "Biosames" for Discussion Around Autumn: Ex-Pharmaceutical Management Director
August 28, 2018
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International regulators are increasingly moving away from comparative efficacy studies (CES) in biosimilar development — long considered a default requirement…
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…