REGULATORY

• 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

• 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

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