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
- Nipro’s Sakigake-Designated Spinal Cord Injury Stem Cell Treatment Up for Approval Review on Nov. 21: MHLW
November 9, 2018
- LDP Conducts Hearing with Pharma Trade Groups for FY2019 Budgets, Tax Reform
November 9, 2018
- LDP Health Bigwigs Agree to Push for October 2019 Revision
November 9, 2018
- Experts Say ICER Deduction Unscientific, MHLW Proposes Different Thresholds for Cancer and Orphan Drugs
November 8, 2018
- Chuikyo Supports Price Raise Rules for Cost-Effective Products
November 8, 2018
- MHLW Pitches “Tiered Model” for CEA Price Tweak, but Faces Chuikyo Opposition
November 8, 2018
- FY2019 Tax Reform Debate Going into Full Swing; Will Pharma Industry Win Expansion in R&D Credit?
November 7, 2018
- Freeze-Dried BCG Vaccine Shipment Suspended due to Arsenic in Diluent; MHLW Panel Calls for Switch to New Product
November 7, 2018
- MHLW Sets Carcinogen Limits in ARBs after Valsartan Impurity Issue
November 6, 2018
- AMED Study Group to Draft Guidelines to Promote Expanded Indications for Neuropathic Pain Drugs
November 6, 2018
- Advocacy Groups Submit Petition for Rubella Prevention, Control Measures to LDP Committee
November 6, 2018
- Public-Private Policy Dialogue Set for November 12
November 5, 2018
- LDP’s Eto Study Group Opposes 2-Stage Revision in 2019
November 2, 2018
- MHLW Asks 5 Prefectures to Cooperate in Distribution of MR Vaccines
November 2, 2018
- MHLW Panel to Discuss Changing Current Transitional Period for Pneumococcal Vaccinations in Elderly
November 2, 2018
- Chuikyo Leaning towards Drug Price Revision in October 2019 in Conjunction with Tax Hike
November 1, 2018
- Infection Specialist Proposes to Set Up Vaccination Council within Cabinet Office
October 31, 2018
- Daiichi Sankyo to Use MID-NET Database for Pralia PMS; Second Case from Private Sector
October 31, 2018
- MHLW Council to Discuss Otsuka’s Nalmefene for Treatment of Alcohol Dependency on Nov. 9
October 29, 2018
- ViiV’s HIV Med Juluca Up for MHLW Panel Review on Nov. 8
October 26, 2018
ページ
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…