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REGULATORY
- 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
- Japan Eyes State Funds to Boost Sakigake Review Staffers: FY2019 Budget Request
August 27, 2018
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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…