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
- Japan Eyes State Funds to Boost Sakigake Review Staffers: FY2019 Budget Request
August 27, 2018
- MHLW to Expand MID-NET and Coordinate with Other Databases and Registries to Improve Safety Measures: Official
August 27, 2018
- It’s Too Early to Introduce Incentives for Biosimilar Use: MHLW Official
August 27, 2018
- MHLW to Issue Optimal Use Guidelines for Imfinzi, Might Make Changes on Latest Data
August 23, 2018
- MHLW Orders Label Revisions for 7 Flu Drugs Including Tamiflu
August 23, 2018
- Chuikyo Discusses ICER Evaluations for Drugs with Multiple Indications
August 23, 2018
- Chuikyo to Allow “Ranged” ICER Values in Cost-Effective Assessment
August 23, 2018
- Chuikyo Members Call for More Info Disclosure for CEA Scheme
August 23, 2018
- Chuikyo OKs Pricing of Entyvio, Imfinzi, Gazyva and More; Listing on Aug. 29
August 22, 2018
- MHLW OKs Opdivo’s Add’l Indications and Flat Dose, 1st-Line Tagrisso Use and More
August 22, 2018
- Just Months after Big Re-Pricing, Opdivo Faces 37.5% Price Slash on Dose Change
August 22, 2018
- Impasse Continues over Mumps Vaccine Inclusion in Public Immunization Programs
August 20, 2018
- MHLW Panel to Review Kyorin’s OAB Drug Vibegron and More on Aug. 30
August 17, 2018
- MHLW Revving Up Biosimilar Drive with Educational Workshop for Healthcare Pros
August 17, 2018
- Astellas AML Drug, Pfizer’s Lorlatinib Up for MHLW Panel Review on Aug. 29
August 16, 2018
- Japan Approves Nesp “Biosame,” Eyes Riveted on December Listing
August 16, 2018
- Collaboration Research Project between Ministries Aims to Develop AI by FY2021 for Drug Discovery for Lung Cancer, IPF
August 16, 2018
- EFPIA Japan Proposes Establishing Organization Formed by Multiple Companies for Blood Collection Operation
August 10, 2018
- No Applications Yet for “Certificated Data Operator” under Medical Infrastructure Law; Govt Hoping for First Certification in FY2018
August 9, 2018
- First Drug Maker Applies to Use MID-NET: PMDA
August 7, 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…