Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
HOME > REGULATORY
REGULATORY
- 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
- LDP Closes Discussions on Fee Cuts to Be Imposed on Hospitals, Pharmacies with Low Price Settlement Rates
February 25, 2014
- MHLW to Set Up Complaint Hotline for Hospitals, Pharmacies Upon Introduction of Penalty for Low Price Settlement Rates
February 25, 2014
- Astellas Unit, 12 Others Prequalified for Expedited Product Importation under FDA Pilot Program
February 21, 2014
- PFSB Issues Director Notification Calling for Revision of Package Inserts for Products Including Kiklin, Stivarga
February 20, 2014
ページ
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…
Following Hisamitsu Pharmaceutical’s decision to go private through a roughly 400 billion yen management buyout (MBO), industry observers are weighing…
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…