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REGULATORY
- Shorter Booster Interval for All Citizens Difficult: Health Minister
December 8, 2021
- Written Pledge Rule on Generic Listing to Continue after 2021; Companies Feel Pressure for Stable Supplies
December 7, 2021
- BMS’ Second CAR-T Therapy Ide-Cel in Line for Approval in January
December 7, 2021
- MHLW to Prepare List of Priority Infectious Diseases by March-End, Set Up Study Group in December
December 7, 2021
- Japan Panels Agree to Add Myocarditis as ADRs for Pfizer, Moderna Vaccines
December 6, 2021
- 2 mRNA Jabs Ordered to Add Myocarditis to ADR List: Label Revision
December 6, 2021
- Panel OKs Outline of Emergency Approval System Based on “Presumed” Efficacy
December 6, 2021
- MHLW Issues Revised Drug Distribution Guidelines; Effective January 1
December 6, 2021
- MOF Panel’s Budget Proposal Pushes Macroeconomic Indexing, No Adjustment Rate
December 6, 2021
- Pharma Industry Wants Grace Period of at Least 5 Years for Spillover Exclusion Rule
December 6, 2021
- Japan Generic Share at 79% in September 2021: Drug Price Survey
December 6, 2021
- 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
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