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REGULATORY
- Average NHI-Market Price Gap of Listed Drugs at 7.6%: MHLW
December 3, 2021
- Amgen’s KRAS Inhibitor, MSD’s Cough Drug Sail through PAFSC, January Approval Likely
December 3, 2021
- 70% of Pharmacies Procured Alternative Products due to Generic Scandals in FY2020: Chuikyo Survey
December 3, 2021
- Chuikyo Defers Coverage for SaMD for Breast Cancer Recurrence Risk Assessment; Software Remains Incomplete
December 3, 2021
- MHLW Eyes Emergency Approval System Based on “Presumed” Efficacy
December 2, 2021
- Chuikyo OKs 2022 Reform Outline for Cost-Effectiveness Assessment System
December 2, 2021
- Chuikyo Reps Acknowledge Need for Adjustment Rate: 2022 Price Revision
December 2, 2021
- Chuikyo Members Call for Restrictions in Re-Pricing Exclusions from Spillover Rule
December 2, 2021
- ICH Adopts E8, M8 Guidelines; 3 Topics Reach Step 2
December 2, 2021
- MHLW to Conduct Supply Chain Survey for Key Drugs
December 1, 2021
- LDP Pharma Study Group Urges 2% Adjustment Rate Plus Certain Range for 2022 Price Revision
December 1, 2021
- Japan Confirms 1st Case of Omicron Variant: MHLW
December 1, 2021
- MHLW Plans March Listing for “Off-Year” 2023
November 30, 2021
- Alzheimer’s Drugs in Mind, MHLW to Float New Rule for Potential Super Big Sellers
November 30, 2021
- 227 Billion Yen for Dual Use Manufacturing Facilities: FY2021 METI Extra Budget
November 29, 2021
- MHLW Earmarks 608 Billion Yen for COVID-19 Drug Initiatives: FY2021 Extra Budget
November 29, 2021
- Idorsia’s Cerebral Vasospasm Drug, Efient Label Expansion Clear PAFSC
November 29, 2021
- PMDA Reviewing Safety Risk of Imusera/Gilenya
November 29, 2021
- Olumiant Gets Sakigake Tag for Type I IFN Autoinflammatory Diseases
November 29, 2021
- PMDA Plans to Cut Review Fees for Fertility Treatments in January
November 26, 2021
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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…