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
- Maviret, Ibrance, PD-1 Inhibitors under PMDA Risk Review
January 21, 2019
- MHLW to Give Enough Preparation Time for Local Govts before New PMD Law Takes Effect
January 21, 2019
- Iron Deficiency Med Ferinject Up for MHLW Panel Review on Jan. 31; No Vyvanse Discussion This Time
January 18, 2019
- MHLW Panels Find No Major Safety Concern for 14 Vaccines: July-October
January 17, 2019
- 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
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International regulators are increasingly moving away from comparative efficacy studies (CES) in biosimilar development — long considered a default requirement…
I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…
The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…