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
- Nearly 1 Million People Newly Diagnosed with Cancer in Japan in 2016: MHLW
January 17, 2019
- Janssen’s Xtandi Rival Up for MHLW Panel Review on Jan. 30; Enbrel Biosimilars Also on Agenda
January 17, 2019
- PMDA to Specify Target Overall Review Period for Regenerative Medicine Products: FY2019-2023 Plan
January 17, 2019
- PMDA to Raise Its Service Fees, Up 28% for New Drug Reviews; MHLW Invites Public Opinions
January 17, 2019
- Chuikyo OKs Pricing Rule Revision for October Re-Pricing; Stemirac to Be Priced as Medicine
January 16, 2019
- MHLW Won’t Necessarily Push March Announcement of New Drug Prices: Bureau Head
January 16, 2019
- PMDA to Raise Fees and Expand Workforce to Boost Review and Safety Measures, GMP Inspection
January 15, 2019
- MHLW Panel OKs 5-Year Extension of Pneumovax Transitional Measure
January 11, 2019
- MHLW Orders Label Revisions for Inlyta, Spinraza, and More
January 11, 2019
- New NHI Prices Will Be Announced “at Most Appropriate Time”: MHLW Official
January 10, 2019
- 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
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