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
- MHLW to Revise Biosimilar Guidelines to Increase Efficiency in Development, Review; Final Draft Expected in FY2019
January 10, 2019
- MHLW Approves Amgen/Astellas’ Evenity, Gilead Sciences’ Epclusa and More
January 9, 2019
- Amendment of PMD Law Will Be Top Priority in 2019: MHLW Bureau Chief Miyamoto
January 8, 2019
- MHLW to Follow Up on Drug Makers’ Efforts to Observe New Detailing Guidelines
January 7, 2019
- Gilead’s Bictegravir, BioCryst’s BCX7353 Get Orphan Status
January 7, 2019
- Orphan Status Given to ReproCELL’s Adipose-Derived Mesenchymal Stem Cell Therapy
December 27, 2018
- MHLW Draft Budget Earmarks 8.99 Billion Yen for Drug-Related Projects
December 26, 2018
- 44 Million Yen Allotted to Fuel Biologics Development: Health Policy Bureau’s FY2019 Budget
December 26, 2018
- Japan OKs FY2019 Budget, Record 34.6 Trillion Yen Earmarked for Social Security
December 25, 2018
- MHLW OKs Add’l Indications for Keytruda, Tecentriq, Hemlibra, and More
December 25, 2018
- After Settling on October 2019 Re-Pricing, When Will Govt Reveal New Drug Prices?
December 21, 2018
- Clarify Definition of Ads to Not Hamper Info Delivery to Patients: PhRMA Tells Govt
December 21, 2018
- CEFP Finalizes Govt Reform Timeline Urging FY2019 Debate on “Economic Evaluations” for Reimbursement Decisions
December 21, 2018
- Approvals for Epclusa, Keytruda’s MSI-H Indication and More Could Be Delayed into 2019
December 21, 2018
- Chuikyo Snubs Industry’s Call to Exclude Listed Products from CEA Scope
December 20, 2018
- PhRMA, EFPIA Pitch Enhanced Appraisal Model for Japan HTA Plan; Chuikyo Reps Acknowledge ICER Limitations
December 20, 2018
- Govt to Pare Drug Prices by 2.4% in October 2019 Ad-Hoc Re-Pricing
December 19, 2018
- MHLW Revises Conditions of Approval for Alecensa Based on Findings from Post-Marketing Survey
December 19, 2018
- MHLW Compiles Proposal for PMD Law Amendment, Eyes Diet Submission of Related Bill Next Year
December 18, 2018
- Ministers Agree on Ad-Hoc Drug Re-Pricing in October 2019, 29 Billion Yen Saving in State Coffers
December 18, 2018
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