REGULATORY

• MHLW’s COVID-19 Guide Adds MSD’s Molnupiravir
  January 6, 2022

• Japan’s Drug Production Down 1.9% to 9.3 Trillion Yen in 2020: MHLW
  January 6, 2022

• Japan Govt to End Observational Avigan Study for COVID-19
  January 5, 2022

• MHLW Finalizes Paper on Emergency Approval System, Set to Submit Bill Next Year
  December 28, 2021

• 50 Million Yen Earmarked to Support API Stockpiles to Ensure Stable Supplies: MHLW FY2022 Budget
  December 28, 2021

• Japan Approves Lenvima/Keytruda Pair, Opdivo Label Expansion
  December 27, 2021

• Payer, Healthcare Reps Call for Stable Supply Measures for Achieving New Generic Share Target: Chuikyo
  December 27, 2021

• Sakigake Status Dropped for GSK’s Biliary Tract Cancer Drug
  December 27, 2021

• Second Case of TTS with Possible Link to AstraZeneca COVID-19 Vaccine Reported in Japan
  December 27, 2021

• Japan Does Not Recommend Ronapreve for Omicron Variant
  December 27, 2021

• 145 Million Yen Allocated for 3 New Projects to Shake Off Public Distrust in Generics: MHLW FY2022 Budget
  December 27, 2021

• Japan Secures 18 Million Extra Doses of Moderna Vaccines
  December 27, 2021

• Japan Approves MSD’s Oral COVID-19 Drug Molnupiravir
  December 27, 2021

• Regulatory Reform Panel Urges Better Trial Environment, SaMD Review
  December 24, 2021

• MHLW to Set Up New Working Group to Discuss Technical Issues in Distribution: Ryukaikon
  December 24, 2021

• New Generic Target Enshrined in Govt’s Updated Fiscal Reform Timeline
  December 24, 2021

• Japan Panel OKs HPV “Catch-Up” Shots for Females Born in FY1997-FY2005
  December 24, 2021

• Ronapreve Given to Nearly 37,000 People in Japan by November, Xevudy to 270: MHLW
  December 24, 2021

• MHLW Eyes Information Provisioning on Generic Supplies by Individual Brands
  December 24, 2021

• Japan to Revise PMD Law to Create Emergency Approval System, Final Paper Due Out by Year-End
  December 23, 2021

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