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
- 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
- Japan Approves Jardiance for Heart Failure, Label Expansions for Opdivo and Keytruda
November 26, 2021
- Verify Adjustment Rate, Review Pricing Rule with Cost-Benefit Standpoint: CEFP
November 26, 2021
- Pharma Pushes 2% Adjustment Rate Plus Certain Range in 2022 Drug Price Revision
November 26, 2021
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