Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
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REGULATORY
- FY2014 NHI Revision Sees Price Cut of 5.64% without Tax Surcharges, 1,118 Long-Listed Products Subject to New Rule
March 5, 2014
- MHLW to Draft Guidelines to Prevent Misuse of Research Funding, Improper Research Activities
March 5, 2014
- Planned Japanese NIH is Research Supporting Agency, Different from Original: Gov't
March 4, 2014
- MHLW Requests University of Tokyo to Investigate SIGN Trial Issues
March 4, 2014
- Drugs Under Ongoing Review for Risk by PMDA Include Mirtazapine for QT Prolongation and Ventricular Tachycardia
March 4, 2014
- PMDA Kansai Branch Poised to Offer More Regulatory Affairs Advice, Inspection Unit to Go Live in April
March 4, 2014
- MHLW Approves 31 APIs for New Ethical Drugs in 2013
March 3, 2014
- PAFSC’s Second Committee Recommends Approval for H5N1 Vaccines
March 3, 2014
- PFSB Issues Safety Information on Thrombosis Associated with YAZ Combination Tablets
March 3, 2014
- MHLW Stresses the Importance of Maintaining Quality of GMP Inspections Following Japan’s Accession to PIC/S
March 3, 2014
- PMDA Begins Disclosing Information on ADRs Reported by Patients through Online Patient ADR Reporting System
February 28, 2014
- Ministry Joint Panel Says Evidence Linking HPV Vaccine Adjuvant with Side Effects Weak
February 27, 2014
- Ethics Code for Epidemiological, Clinical Research to Call for COI Management, Whistle-Blowing: Draft
February 27, 2014
- PFSB Issues Notification on Marketing Authorization Applications for In Vitro Companion Diagnostics
February 27, 2014
- US FDA, EMA Hold Monthly Regulatory Working-Level Talks, with Participation of PMDA as Observer
February 27, 2014
- EMA Recommends Approval for Fixed-Dose Combination of Canagliflozin, Metformin
February 27, 2014
- Cabinet OKs Bill to Merge NIBIO, NIHN to Create New Institute
February 26, 2014
- PAFSC’s First Committee Supports Approval of Novel Antiplatelet Agent Prasugrel
February 25, 2014
- Penalty for Lengthy Drug Delivery Talks Will Lift Price Settlement Rates: Minister
February 25, 2014
- MHLW May Take Harsh Action against Novartis over Diovan Raids: Minister Tamura
February 25, 2014
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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…